Prolong NexGenRecalls & reported problems across all models
Zimmer, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 0
We found 9 models of Prolong NexGen by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2019 and Dec 2, 2025 — classified as 36 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (6 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 Prolong NexGen problems
Device problems
- Adverse Event Without Identified Device or Use Problem27
- Difficult to Insert6
- Unstable6
- Naturally Worn3
- Device Contaminated During Manufacture or Shipping2
- Material Erosion2
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Loss of Range of Motion12
- Pain12
- Scar Tissue8
- Insufficient Information5
- Joint Laxity5
- Adhesion(s)4
- Failure of Implant4
- No Clinical Signs, Symptoms or Conditions4
Prolong NexGen models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prolong® NexGen® 5952-40-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- Prolong® NexGen® 5952-40-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- Prolong® NexGen® 5952-30-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Prolong® NexGen® 5952-30-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- Prolong® NexGen® 5952-50-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- Prolong® NexGen® 5952-30-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Prolong® NexGen® 5952-40-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Prolong® NexGen® 5952-50-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Prolong® NexGen® 5952-21-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent Prolong NexGen adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL KNEE SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT PRESENTED INFECTION AND LOOSENING OF TIBIAL AND FEMORAL COMPONENTS LEADING TO A REVISION SURGERY. THE SURGEON REMOVED ALL COMPONENTS AND REPLACED THEM WITH A SPACER. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Medical device site infection; Septic loosening
MAUDE report 23694361 ↗InjuryAug 12, 2025Material Erosion; Material Erosion
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY FOUR (4) WEEKS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE RECURRENT, ATRAUMATIC HEMARTHROSIS. SUBSEQUENTLY, SEVEN (7) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY. THE ARTICULAR SURFACE WAS FOUND TO HAVE CLEAR SIGNS OF ABRASION AND WAS REPLACED WITHOUT COMPLICATION. THE TIBIAL AND FEMORAL COMPONENTS REMAIN IMPLANTED. DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Hemarthrosis; Loss of Range of Motion; Pain; Swelling/ Edema
MAUDE report 22783909 ↗InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION REPORTED.
Patient problems: Muscle/Tendon Damage; Rupture
MAUDE report 21312557 ↗InjuryDec 11, 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 Laxity
MAUDE report 20903218 ↗InjuryNov 11, 2024Adverse 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: Insufficient Information; Joint Laxity
MAUDE report 20652231 ↗InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR YEARS AND THREE MONTHS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20517946 ↗InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE NINE MONTHS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19599706 ↗InjuryJun 14, 2024Adverse 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: Insufficient Information
MAUDE report 19536054 ↗InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND ARTHROFIBROSIS POST IMPLANTATION. DURING THE PROCEDURE THE SURGEON WAS ABLE TO BREAK UP ADHESIONS AND SCAR TISSUE INCREASING RANGE OF MOTION. NO MORE INFORMATION IS AVAILABLE.
Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue
MAUDE report 19532376 ↗InjuryMar 20, 2024Unstable; Naturally Worn; Unstable; Naturally Worn
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS PAIN AND INSTABILITY SECONDARY TO POLYETHYLENE WEAR APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. DURING THE PROCEDURE, THE FEMORAL AND TIBIAL TRAY COMPONENTS WERE FOUND TO BE STABLE AND REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 18940841 ↗MalfunctionJan 3, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18437292 ↗InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO PAIN. THE SURGEON RESURFACED THE PATELLA AND EXCHANGED THE ARTICULAR SURFACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 18426117 ↗MalfunctionNov 20, 2023Difficult 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 18169809 ↗InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION DUE TO PROGRESSIVE PCL INSUFFICIENCY AND SUBSEQUENT INSTABILITY AS A RESULT OF RHEUMATOID ARTHRITIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 18136400 ↗InjuryOct 30, 2023Unstable; Naturally Worn; Unstable; Naturally Worn
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE EIGHT YEARS POST IMPLANTATION DUE TO IMPLANT WEAR AND INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
Patient problems: Erosion; Failure of Implant
MAUDE report 18031982 ↗
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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