Gender SolutionsRecalls & reported problems across all models
Zimmer, Inc. · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 7 models of Gender Solutions by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2020 and Sep 13, 2026 — classified as 9 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (5 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 problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Positioning Failure5
- Mechanical Jam4
- Fracture3
- Difficult to Insert2
- Insufficient Device Problem Information1
- Material Twisted/Bent1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Pain5
- Adhesion(s)1
- Ambulation or Postural Difficulties1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
- Hypersensitivity/Allergic reaction1
- Insufficient Information1
Gender Solutions models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Gender Solutions® 00-5927-050-00INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT11 reports
- Gender Solutions® 00-5927-060-00INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT3 reports
- Gender Solutions® 00-5926-012-02PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Gender Solutions® 00-5926-013-02PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Gender Solutions® 00-5926-011-02PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Gender Solutions® 00-5926-012-01PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Gender Solutions® 00-5926-014-02PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent Gender Solutions adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747899 ↗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 ↗InjurySep 9, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED THAT THE MILLING BURR COMPONENT OF THE HANDPIECE INSTRUMENT WAS FOUND TO BE BENT AND WAS UNABLE TO BE REMOVED FROM THE MILLING HANDPIECE AFTER SURGERY. THERE WERE NO ISSUES WITH THE DEVICE DURING THE PROCEDURE AND NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20171480 ↗InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: Joint effusion; Pain; Paresthesia; Swelling/ Edema; Tactile Disorders
MAUDE report 19299074 ↗MalfunctionMar 4, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT UPON INSPECTION DURING AN INITIAL SURGERY, THE BURR WAS STUCK IN THE HANDPIECE. STAFF WERE ABLE TO DISLODGE WITH EXTREME FORCE AFTER WASHING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18826362 ↗MalfunctionAug 29, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT AFTER USE OF INSTRUMENT, THE BURR WOULD NOT DISENGAGE FROM THE HANDPIECE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17640960 ↗InjuryAug 8, 2023Adverse 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: Ambulation or Postural Difficulties; Pain
MAUDE report 17480182 ↗MalfunctionMay 10, 2023Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16902626 ↗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 ↗MalfunctionJan 19, 2023Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16206402 ↗MalfunctionJan 19, 2023Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16206400 ↗MalfunctionOct 27, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE DRILL WAS USED TO HOST THE BURR FOR THE PROCEDURE. THE BURR WAS NOT ABLE TO FULLY SEAT AND STAFF TRIED USING A SECOND BURR TIP BUT IT WAS STILL NOT WORKING. A SECOND DRILL WAS OPENED. THERE WAS A 10 MINUTE SURGICAL DELAY TO UNDERSTAND THE ISSUE BETTER AND TO SWAP OUT THE INSTRUMENTS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15680514 ↗MalfunctionOct 27, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE DRILL WAS USED TO HOST THE BURR FOR THE PROCEDURE. THE BURR WAS NOT ABLE TO FULLY SEAT AND STAFF TRIED USING A SECOND BURR TIP BUT IT WAS STILL NOT WORKING. A SECOND DRILL WAS OPENED. THERE WAS A 10 MINUTE SURGICAL DELAY TO UNDERSTAND THE ISSUE BETTER AND TO SWAP OUT THE INSTRUMENTS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15680429 ↗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 ↗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 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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