Gender Solutions® Female (GSF) 00-5764-015-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024192263), received between Feb 15, 2023 and Apr 15, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

19 other recalls cover devices cleared under the same FDA submission (K060370, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA. SUBSEQUENTLY, THEY HAD A REVISION APPROXIMATELY 7 YEARS AND 2 MONTHS POST-IMPLANTATION DUE TO PROGRESSIVELY INCREASING INSTABILITY. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 24888252 ↗
• InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY LEGAL, THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS DEVELOPED SWELLING AND LOOSENING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Swelling/ Edema

  MAUDE report 23630513 ↗
• InjuryMay 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS THE REPORTED BY LEGAL THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED LOOSENING AND IS BEING CONSIDERED FOR A REVISION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 22004815 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 21401610 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS ALLEGING HARM CAUSED BY THE DEVICE APPROXIMATELY SEVEN (7) YEARS FOLLOWING KNEE ARTHROPLASTY; HOWEVER THE NATURE OF THE HARM IS UNKNOWN AND NO MEDICAL INTERVENTION HAS BEEN REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21055071 ↗
• InjurySep 3, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT REPORTS AUDIBLE NOISE AND AMBULATION DIFFICULTIES. NO REVISION PROCEDURE OR INTERVENTION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20130499 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 18959472 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIVE MONTHS POST IMPLANTATION DUE TO FEMORAL FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 18362898 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS SUFFERING FROM KNEE SWELLING AND PAIN FOUR YEARS POST RIGHT KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16378855 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16378000 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060370, 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-1059-2018 · Nov 29, 2017 · Terminated
  CR-FLEX GSF PRECOAT SZ C-L CR-FLEX GSF PRECOAT SZ C-R CR-FLEX GSF PRECOAT SZ D-L CR-FLEX GSF PRECOAT SZ D-R CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R CR-FLEX GSF PRECOA
• Z-1058-2018 · Nov 29, 2017 · Terminated
  CR-FLEX GSF PCT SZ C-R MINUS CR-FLEX GSF PCT SZ D-L MINUS CR-FLEX GSF PCT SZ D-R MINUS CR-FLEX GSF PCT SZ E-L MINUS CR-FLEX GSF PCT SZ E-R MINUS CR-FLEX GSF PCT SZ F-L MINUS CR-FLE
• Z-1056-2018 · Nov 29, 2017 · Terminated
  LPS-FLEX GSF OPT SZ C-L LPS-FLEX GSF OPT SZ C-R LPS-FLEX GSF OPT SZ D-L LPS-FLEX GSF OPT SZ D-R LPS-FLEX GSF OPT SZ E-L LPS-FLEX GSF OPT SZ E-R LPS-FLEX GSK OPT SZ F-L LPS-FLEX GSF
• Z-0830-2016 · Jan 11, 2016 · Terminated
  LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes Product Usage "" This device is indicated for patients with
• Z-0073-2014 · Aug 30, 2013 · Terminated
  NexGen Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX
• Z-0074-2014 · Aug 30, 2013 · Terminated
  NexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF
• Z-0535-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Left, sterile, REF 00-5764-015-51.
• Z-0530-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF 00-5996-016-01.
• Z-0528-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF 00-5996-017-01.
• Z-0533-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51.
• Z-0531-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02.
• Z-0529-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Right, sterile, REF 00-5996-017-02.
• Z-0532-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size E Right, sterile, REF 00-5996-015-02.

…and 4 more.