Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
FDA adverse event reports and recall history for prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer (product code NPJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,136
- Deaths
- 0
- Injuries
- 748
- Malfunctions
- 382
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
- 2018-06-01TerminatedUnder Investigation by firm
Restoris MCK Onlay Insert Extractor.
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
- 2015-10-21TerminatedProcess design
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
May contain small amounts of ethylene glycol residue
- 2015-10-21TerminatedProcess design
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
May contain small amounts of ethylene glycol residue
- 2015-10-21TerminatedProcess design
ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
May contain small amounts of ethylene glycol residue
- 2014-03-04TerminatedError in labeling
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.
The product may be mislabeled and could result in the incorrect implant being used.
- 2012-01-11TerminatedOther
Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland. Intended for use in Unicompartmental Knee Arthroplasty (UKA). Surgeon users have identified the following potential advantages of UKA procedures versus Total Knee Arthroplasty procedures generally: conservation of the opposite compartment, preservation of ligaments and patellofemoral articulation, reduced loss of bone stock and lower implant cost. The EIUS UKA is a Resurfacing device that requires the removal of a thin condylar cross-section intended to replace the diseased cartilage only. This allows the surgeon to conserve good quality subchondral bone.
Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.
- 2005-02-24TerminatedOther
The Triathlon Posteriorly Stabilized Femoral Component.
The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.
- TerminatedUnknown/Undetermined by firm
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
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