Prolong® NexGen® 5952-50-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024208063), received between Jul 20, 2022 and Aug 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Erosion” (1 report).

67 other recalls cover devices cleared under the same FDA submission (K003910, K013991, K173057); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 29, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 16635048 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. APPROXIMATELY 2.5 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS. THE PATIENT EXPRESSES EXTREME SATISFACTION WITHOUT FURTHER COMPLICATIONS.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 15065904 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003910, K013991, K173057. One submission often covers many models, so check the product and lot details in each record.

• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-1586-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height , Steril
• Z-1557-2012 · Feb 24, 2012 · Terminated
  00-5970-020-09, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 9 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Su
• Z-1587-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 14mm Height , Steril
• Z-1562-2012 · Feb 24, 2012 · Terminated
  00-5970-020-20 NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 20 mm Height , Use With Plate 1,2 (5.5 MM un
• Z-1570-2012 · Feb 24, 2012 · Terminated
  00-5972-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Wa
• Z-1568-2012 · Feb 24, 2012 · Terminated
  90-5970-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 20mm Height , Use With Plate 1,2 Sterile R,
• Z-1601-2012 · Feb 24, 2012 · Terminated
  REF 90-5970-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 17 mm Hei
• Z-1576-2012 · Feb 24, 2012 · Terminated
  00-5976-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 12mm Height , Sterile R, Rx ,Zimmer, In
• Z-1602-2012 · Feb 24, 2012 · Terminated
  90-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20 mm Height
• Z-1582-2012 · Feb 24, 2012 · Terminated
  REF 00-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 17mm Height , Ster
• Z-1561-2012 · Feb 24, 2012 · Terminated
  00-5970-020-17, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 17 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Kne
• Z-1588-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 17mm Height , Steril
• Z-1573-2012 · Feb 24, 2012 · Terminated
  00-5972-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 17mm Height , Sterile R, Rx ,Zimmer, Inc. Wa

…and 52 more.