Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
FDA adverse event reports and recall history for prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive (product code PBI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,264
- Deaths
- 2
- Injuries
- 1,063
- Malfunctions
- 1,197
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2014-06-19TerminatedUse error
G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
- 2014-06-19TerminatedUse error
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
Monitor prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.