Gender Solutions® 00-5926-013-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024205864), received between Mar 24, 2022 and Feb 25, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryFeb 25, 2026Insufficient Device Problem Information

  IT IS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY REVISION TO ADDRESS UNKNOWN COMPLICATIONS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24444236 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. OPERATIVE NOTES FROM THE MANIPULATION NOTED ARTHROFIBROSIS, INTRAARTICULAR SCAR WITH IMPINGEMENT AND CHRONIC SYNOVITIS. AN ARTHROSCOPY WITH A SYNOVECTOMY WAS PERFORMED AND THE PATIENT'S RANGE OF MOTION INCREASED FROM 0-110° TO 0-130° DURING THE MANIPULATION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Adhesion(s); Scar Tissue; Synovitis; Unspecified Tissue Injury

  MAUDE report 13896172 ↗

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-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-1053-2018 · Nov 29, 2017 · Terminated
  ZIMMER PATELLA FEMORAL JOINT 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