Gender Solutions® 00-5926-012-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024205840), received between Jul 6, 2022 and Apr 11, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K070695, K173057); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED PATIENT RECEIVED INJECTION IN KNEE FOR PAIN DUE TO IMPINGEMENT ONE YEAR POST OPERATIVE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint Impingement; Pain

  MAUDE report 16713142 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND DECREASED ACTIVITY POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 14928414 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070695, K173057. One submission often covers many models, so check the product and lot details in each record.

• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-1053-2018 · Nov 29, 2017 · Terminated
  ZIMMER PATELLA FEMORAL JOINT Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
• Z-1052-2018 · Nov 29, 2017 · Terminated
  PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
• Z-0837-2016 · Jan 11, 2016 · Terminated
  Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic art
• Z-2545-2014 · Jul 30, 2014 · Terminated
  Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
• Z-0077-2014 · Aug 30, 2013 · Terminated
  Gender Solutions" Patello-Femoral Component