NexGen LegacyRecalls & reported problems across all models
Zimmer, Inc. · 119 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one NexGen Legacy model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 319
- Deaths reported
- 0
- Injuries reported
- 183
- Recalls
- 3
We found 119 models of NexGen Legacy by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 319 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2019 and Sep 22, 2026 — classified as 183 injuries, 136 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (71 reports).
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
NexGen Legacy recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 6, 2025Open, Classified
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Z-1039-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 6, 2025Open, Classified
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Z-1038-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Jul 24, 2017Terminated
There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
Z-0663-2018 · Root cause: Reprocessing Controls · Recall details · FDA record ↗
Most reported NexGen Legacy problems
Device problems
- Adverse Event Without Identified Device or Use Problem102
- Difficult to Insert71
- Positioning Failure33
- Tear, Rip or Hole in Device Packaging18
- Fracture17
- Insufficient Device Problem Information17
- Loosening of Implant Not Related to Bone-Ingrowth16
- Unstable14
Patient problems
- No Clinical Signs, Symptoms or Conditions121
- Pain92
- Insufficient Information39
- Swelling/ Edema37
- Failure of Implant34
- Ambulation or Postural Difficulties33
- Loss of Range of Motion27
- Joint Laxity15
NexGen Legacy models
119 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- NexGen® Legacy® 5964-17-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing1 recall3 reports
- NexGen® Legacy® 5994-22-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- NexGen® Legacy® 5994-32-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- NexGen® Legacy® 5964-32-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- NexGen® Legacy® 5964-32-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- NexGen® Legacy® 5964-40-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- NexGen® Legacy® 5964-40-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- NexGen® Legacy® 5964-40-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- NexGen® Legacy® 5964-32-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- NexGen® Legacy® 5964-15-52Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing7 reports
- NexGen® Legacy® 5964-16-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing7 reports
- NexGen® Legacy® 5964-16-52Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing7 reports
- NexGen® Legacy® 5964-30-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- NexGen® Legacy® 5964-17-52Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing6 reports
- NexGen® Legacy® 5964-30-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- NexGen® Legacy® 5994-17-91PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- NexGen® Legacy® 5964-32-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- NexGen® Legacy® 5994-14-91PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® Legacy® 5994-16-91PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® Legacy® 5994-16-92PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® Legacy® 5964-40-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® Legacy® 5964-15-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing4 reports
- NexGen® Legacy® 5964-22-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NexGen® Legacy® 5994-15-91PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NexGen® Legacy® 5994-17-92PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NexGen® Legacy® 5994-32-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NexGen® Legacy® 5964-22-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NexGen® Legacy® 5994-40-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NexGen® Legacy® 5996-16-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing3 reports
- NexGen® Legacy® 5996-17-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing3 reports
- NexGen® Legacy® 5996-17-52Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing3 reports
- NexGen® Legacy® 5964-22-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® Legacy® 5964-40-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® Legacy® 5964-50-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® Legacy® 5964-50-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® Legacy® 5994-13-91PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® Legacy® 5994-14-92PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® Legacy® 5996-17-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® Legacy® 5964-50-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® Legacy® 5960-15-52Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- NexGen® Legacy® 5964-13-52Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- NexGen® Legacy® 5964-14-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- NexGen® Legacy® 5964-14-52Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- NexGen® Legacy® 5996-14-01Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- NexGen® Legacy® 5996-14-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- NexGen® Legacy® 5996-14-52Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- NexGen® Legacy® 5996-15-02Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- NexGen® Legacy® 5996-16-02Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing2 reports
- NexGen® Legacy® 5964-30-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5964-30-17PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5964-32-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5964-40-23PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5964-42-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 00-5968-015-51PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5994-15-92PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5994-30-20PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5994-32-17PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5994-40-23PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5994-42-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5994-42-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5995-30-12TEMPLATE2 reports
- NexGen® Legacy® 5964-30-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5964-32-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5964-50-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5994-30-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5994-40-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® Legacy® 5960-14-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- NexGen® Legacy® 5960-14-52Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- NexGen® Legacy® 5960-15-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- NexGen® Legacy® 5960-17-51Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- NexGen® Legacy® 5996-16-01Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing1 report
- NexGen® Legacy® 00-5762-015-51PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5960-18-51PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5961-30-10TEMPLATE1 report
- NexGen® Legacy® 5961-40-12TEMPLATE1 report
- NexGen® Legacy® 00-5962-016-52PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 00-5962-017-52PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5964-30-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5964-32-20PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5964-40-17PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5964-42-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5964-42-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5964-42-17PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5964-51-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 00-5968-015-52PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 00-5968-016-52PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 00-5968-017-51PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-13-92PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-22-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-22-20PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-30-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-30-17PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-32-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-32-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-40-17PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-40-20PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-42-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5994-42-17PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NexGen® Legacy® 5995-40-10TEMPLATE1 report
- NexGen® Legacy® 5996-03-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent NexGen Legacy 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
Patient problems: Insufficient Information
MAUDE report 50856858 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent a right knee manipulation under anesthesia to treat pain and loss of range of motion approximately three (3) months following right knee arthroplasty. No additional information is available.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 50412613 ↗MalfunctionAug 6, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50155746 ↗MalfunctionAug 3, 2026Difficult to Insert; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122679 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE. APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN, SWELLING, AND INFLAMMATION. DIAGNOSTIC IMAGING AND PUNCTURES REVEALED FLUID ACCUMULATION DUE TO A RUPTURED BAKER'S CYST HOWEVER NO EVIDENCE OF LOOSENING OR OTHER COMPLICATIONS WERE PRESENT. THE PATIENT THEN BEGAN TO EXPERIENCE DIFFICULTY AMBULATING WITH FURTHER INCREASED PAIN AND SWELLING AFTER SIGNIFICANT ACTIVITY. APPROXIMATELY TEN (10) MONTHS POST SYMPTOM ONSET, AN ADDITIONAL DIAGNOSTIC SAMPLE REVEALED INFECTION IN THE IMPLANTED JOINT. SUBSEQUENT INTERVENTION AS A RESULT OF THE CONFIRMED INFECTION HAS NOT BEEN REPORTED AND THE DEVICES REMAIN IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Cyst(s); Inflammation; Medical device site infection; Pain; Swelling/ Edema
MAUDE report 25693090 ↗InjuryJun 11, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TWO (2) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE DISCOMFORT AND IT WAS DETERMINED THAT THE TIBIAL BEARING HAD DISASSOCIATED FROM THE TIBIAL TRAY. THE PATIENT UNDERWENT REVISION SURGERY AND THE BEARING WAS EXCHANGED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Discomfort
MAUDE report 25477372 ↗MalfunctionMay 22, 2026Positioning Failure
IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT MATE PROPERLY WITH THE TIBIAL TRAY. A SECONDARY DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25255357 ↗MalfunctionApr 23, 2026Difficult to Insert
IT WAS REPORTED THAT THE LINER CANNOT BE ASSEMBLED TO MATE WITH THE TIBIAL TRAY. THE SURGICAL TECHNIQUE WAS UTILIZED. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETE WITH A SECOND LINER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965467 ↗MalfunctionApr 21, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING A PROCEDURE, THE INNER PACKAGING OF A STERILE IMPLANT WAS FOUND CRACKED AND THE DEVICE WAS NOT USED. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942424 ↗InjuryMar 16, 2026Insufficient Device Problem Information
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24608732 ↗MalfunctionFeb 26, 2026Delivered as Unsterile Product
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457945 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAS EXPERIENCE DISCOMFORT IN HIS KNEE APPROXIMATELY 2 YEARS POST IMPLANTATION, HE UNDERWENT A SCINTIGRAPHY, WHICH REVEALED TIBIAL LOOSENING, SO A KNEE REVISION WAS SCHEDULED. THE PATIENT HAD A REVISION SURGERY 2 YEARS POST IMPLANTATION, AND THE POLYETHYLENE HAS BEEN REPLACED, AS NO LOOSENING WAS OBSERVED IN THE TIBIAL AND FEMORAL IMPLANTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Discomfort
MAUDE report 24442724 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY 9 YEARS POST-IMPLANTATION DUE TO PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain
MAUDE report 24271831 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY NINE YEARS FOUR MONTHS POST IMPLANTATION DUE TO PAIN. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Pain
MAUDE report 24208912 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening; Osteolysis
MAUDE report 24072724 ↗
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
- Alliance32 models · 275 reports · 2 recalls
- Comprehensive18 models · 103 reports · 3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page