Prosthesis, Toe, Hemi-, Phalangeal
FDA adverse event reports and recall history for prosthesis, toe, hemi-, phalangeal (product code KWD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 289
- Deaths
- 0
- Injuries
- 242
- Malfunctions
- 37
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2014-12-16TerminatedNonconforming Material/Component
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
- 2008-09-18TerminatedLabeling mix-ups
Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplasty.
Labeling presented conflicting information as to whether device was sterile or not.
- TerminatedProcess control
SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- TerminatedLabeling design
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- TerminatedLabeling design
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- TerminatedLabeling design
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- TerminatedLabeling design
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- TerminatedLabeling design
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- TerminatedLabeling design
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- TerminatedLabeling design
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
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