Gender Solutions® Female (GSF) 00-5764-015-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024192256), received between Apr 26, 2022 and Sep 22, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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.

• InjurySep 22, 2026Insufficient Device Problem Information

  It was reported that the patient is experiencing unknown complications approximately nine (9) years following left knee arthroplasty.No additional information is available.

  Patient problems: Insufficient Information

  MAUDE report 50856813 ↗
• InjuryFeb 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY LEGAL A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, A LEGAL CLAIM HAS BEEN MADE DUE TO PAIN AND LIMITED MOBILITY. IT WAS NOTED THAT THE SURGEON REPORTED LOOSENING VIA X-RAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain

  MAUDE report 24390492 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS POST IMPLANTATION OF AN INITIAL LEFT KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO STIFFNESS, PAIN, AND REDUCED RANGE OF MOTION IN THE KNEE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 23817409 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS POST IMPLANTATION OF AN INITIAL LEFT KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO STIFFNESS, PAIN, AND REDUCED RANGE OF MOTION IN THE KNEE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 22783334 ↗
• InjuryJun 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO PAIN AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. DURING THE REVISION THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE, THE PATELLA AND TIBIA WERE WELL FIXED AND RETAINED. THE FEMORAL COMPONENT WAS REVISED WITHOUT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22307336 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY SEVEN (7) YEARS AND NINE (9) MONTHS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21085410 ↗
• InjuryMar 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Insufficient Information

  MAUDE report 18891073 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS UNKNOWN COMPLICATIONS APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18628097 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE PROCEDURE. SUBSEQUENTLY, A FEW WEEKS POST-IMPLANTATION, THE PATIENT TWISTED THEIR KNEE. THE PATIENT WAS REVISED TO PAIN.

  Patient problems: Pain

  MAUDE report 18400929 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE MANIPULATION UNDER ANESTHESIA APPROXIMATELY THREE MONTHS POST-IMPLANTATION TO INCREASE RANGE OF MOTION. THE PATIENT REPORTS STILL EXPERIENCING PAIN, SWELLING, AND INSUFFICIENT RANGE OF MOTION, NECESSITATING CONTINUED TRIPS TO PHYSICAL THERAPY. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

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

  MAUDE report 14205666 ↗

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-0529-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Right, sterile, REF 00-5996-017-02.
• 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-0536-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52.
• Z-0534-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size F Right, sterile, REF 00-5764-016-52.
• 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-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-0528-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF 00-5996-017-01.

…and 4 more.