Gender Solutions Female (GSF)Recalls & reported problems across all models
Zimmer, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls
- 0
We found 17 models of Gender Solutions Female (GSF) by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Jan 15, 2020 and Sep 22, 2026 — classified as 44 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Gender Solutions Female (GSF) problems
Device problems
- Adverse Event Without Identified Device or Use Problem29
- Loosening of Implant Not Related to Bone-Ingrowth11
- Insufficient Device Problem Information3
- Tear, Rip or Hole in Device Packaging3
- Device Dislodged or Dislocated2
- Noise, Audible1
- Off-Label Use1
- Packaging Problem1
Patient problems
- Pain17
- Insufficient Information11
- Loss of Range of Motion9
- Swelling/ Edema9
- Aseptic loosening7
- Bone Fracture(s)3
- Failure of Implant3
- Ambulation or Postural Difficulties2
Gender Solutions Female (GSF) models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Gender Solutions® Female (GSF) 00-5764-015-51PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- Gender Solutions® Female (GSF) 00-5764-015-52PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- Gender Solutions® Female (GSF) 00-5764-014-52PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Gender Solutions® Female (GSF) 00-5764-016-52PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- Gender Solutions® Female (GSF) 00-5750-015-06PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Gender Solutions® Female (GSF) 00-5750-015-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5750-015-05PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5764-013-51PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5764-014-51PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5764-016-51PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5750-014-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Gender Solutions® Female (GSF) 00-5750-015-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Gender Solutions® Female (GSF) 00-5750-016-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Gender Solutions® Female (GSF) 00-5750-016-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Gender Solutions® Female (GSF) 00-5750-016-06PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Gender Solutions® Female (GSF) 00-5764-017-51PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Gender Solutions® Female (GSF) 00-5764-017-52PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent Gender Solutions Female (GSF) adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO A MOTOR VEHICLE ACCIDENT WHICH CAUSED A FRACTURE OF THE DISTAL FEMUR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Periprosthetic fracture
MAUDE report 25390874 ↗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 ↗InjuryMar 16, 2026Insufficient Device Problem Information
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24608699 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD AND INITIAL TKA. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24559367 ↗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 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION.
Patient problems: Arthrofibrosis; Unspecified Infection
MAUDE report 23840670 ↗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 ↗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 ↗InjuryNov 10, 2025Loosening 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: Aseptic loosening
MAUDE report 23509216 ↗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 ↗InjuryJul 9, 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: Cyst(s); Pain; Septic loosening; Unspecified Infection
MAUDE report 22461412 ↗InjuryJun 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY ABOUT FOUR YEARS AGO. PATIENT IS CLAIMING/EXPERIENCING INCREASING PAIN, AND BONE SCAN REVEALED ASEPTIC LOOSENING PER PATIENT. NO REVISION HAS BEEN REPORTED AT THIS TIME.
Patient problems: Aseptic loosening; Pain
MAUDE report 22357966 ↗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 ↗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 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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