NexGen Complete Knee SolutionRecalls & reported problems across all models
Zimmer, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one NexGen Complete Knee Solution model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 10 models of NexGen Complete Knee Solution by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2024 and Jul 14, 2026 — classified as 6 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (8 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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 Complete Knee Solution 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.
- Feb 27, 2025Open, Classified
The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
Z-1433-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported NexGen Complete Knee Solution problems
Device problems
- Difficult to Insert8
- Positioning Failure8
- Fracture3
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Insufficient Cooling1
- Noise, Audible1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information2
- Joint Laxity2
- Failure of Implant1
- Joint Dislocation1
- Loss of Range of Motion1
NexGen Complete Knee Solution models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NexGen® Complete Knee Solution 5962-42-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall2 reports
- NexGen® Complete Knee Solution 5962-40-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER7 reports
- NexGen® Complete Knee Solution 5962-40-12PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- NexGen® Complete Knee Solution 5962-22-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- NexGen® Complete Knee Solution 5962-32-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- NexGen® Complete Knee Solution 5962-22-12PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- NexGen® Complete Knee Solution 00-5962-024-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- NexGen® Complete Knee Solution 5962-30-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- NexGen® Complete Knee Solution 5962-40-17PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- NexGen® Complete Knee Solution 5962-50-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent NexGen Complete Knee Solution adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. APPROXIMATELY 1 YEAR POST-OP, THE PATIENT WAS REVISED DUE TO FIXED FLEXION STIFFNESS. THE TIBIAL COMPONENT WAS REMOVED AND THE BONE WAS RESECTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Loss of Range of Motion
MAUDE report 25815921 ↗MalfunctionJul 9, 2026Difficult to Insert
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT A POLYETHYLENE INSERT DID NOT LOCK INTO THE TIBIAL BASEPLATE. A SECOND INSERT OF THE SAME SIZE WAS OPENED INTRA-OPERATIVELY AND LOCKED PROPERLY. 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 25762090 ↗InjuryApr 27, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS ARTICULAR SURFACE DISLOCATION APPROXIMATELY FOUR (4) YEARS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 25001930 ↗InjuryMar 18, 2026Fracture; Unstable; Noise, Audible
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS INSTABILITY AND AUDIBLE NOISE FROM THE KNEE SECONDARY TO POLYETHYLENE IMPLANT FRACTURE APPROXIMATELY NINE (9) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Laxity
MAUDE report 24629743 ↗MalfunctionJan 5, 2026Positioning Failure
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23962286 ↗MalfunctionDec 2, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696694 ↗InjuryNov 25, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23644765 ↗MalfunctionNov 5, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479250 ↗MalfunctionAug 21, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THE TIBIAL LINER WOULD NOT MATE INTO THE TIBIAL TRAY. ANOTHER LINER WAS USED TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22868118 ↗MalfunctionJul 16, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THE LINER WOULD NOT ASSEMBLE WITH THE MATING TIBIAL TRAY. THERE WAS A 20 MINS DELAY. FINALLY SURGEON USED SIZE 10MM LINER TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22519983 ↗MalfunctionJun 3, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE LINER WOULD NOT ASSEMBLE WITH THE TIBIAL TRAY RESULTING IN A 1-HOUR DELAY WAITING FOR ANOTHER LINER. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135532 ↗MalfunctionMay 16, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036397 ↗MalfunctionMay 16, 2025Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22034893 ↗InjuryMay 12, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. APPROXIMATELY SEVEN YEARS POST-OPERATION, THE PATIENT STOOD UP AND FELT A POP AND EXPERIENCED INSTABILITY. SUBSEQUENTLY, THE PATIENT WAS REVISED AND DURING THE REVISION SURGERY, THE PS POST WAS FOUND BROKEN. A POLY SWAP WAS PERFORMED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 22002836 ↗MalfunctionMay 6, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE COULD NOT BE SEATED ON THE TIBIAL TRAY. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21970764 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page