Prolong® NexGen® 5952-40-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024208025), received between Feb 19, 2020 and Feb 5, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO POOR FLEXION AND ANTERIOR KNEE PAIN. THE PATELLA WAS RESURFACED, AND THE LINER WAS EXCHANGED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16912987 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO ARTHROFIBROSIS WHICH CAUSED LIMITED RANGE OF MOTION AND STIFFNESS. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION AND ALL IMPLANTS REMAIN IN PLACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 16555091 ↗
• InjuryJul 8, 2021Adverse 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; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12135930 ↗
• InjuryJun 11, 2021Adverse 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; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 11984162 ↗
• MalfunctionMar 10, 2020Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT, UPON TRYING TO INSERT THE ARTICULAR SURFACE, THE SURGEON COULD NOT GET IT TO ENGAGE ON THE TIBIAL TRAY. BETWEEN ATTEMPTS; HE CLEARED SOFT TISSUE, RE-POSITIONED RETRACTORS, AND VISUALLY CHECKED THAT THERE WERE NO OBSTRUCTIONS. AFTER THREE UNSUCCESSFUL ATTEMPTS, A NEW IMPLANT WAS OPENED TO COMPLETE THE PROCEDURE. NEW IMPLANT ENGAGED ON THE FIRST ATTEMPT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9811385 ↗
• MalfunctionFeb 19, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED DEVICE EXHIBITED PACKAGING DAMAGE, WHICH MAY HAVE POTENTIALLY COMPROMISED STERILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9727300 ↗

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-1581-2012 · Feb 24, 2012 · Terminated
  REF 00-5952-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 14mm Height , Ster
• Z-1572-2012 · Feb 24, 2012 · Terminated
  00-5972-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 14 mm Height , Sterile R, Rx ,Zimmer, Inc. W
• 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
• Z-1584-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 9mm Height , Sterile
• Z-1594-2012 · Feb 24, 2012 · Terminated
  REF 00-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 14mm Height , Steril
• Z-1607-2012 · Feb 24, 2012 · Terminated
  00-5976-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 17 mm Height , Steril
• Z-1585-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height , Steril
• Z-1592-2012 · Feb 24, 2012 · Terminated
  REF 00-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height , Steril
• Z-1563-2012 · Feb 24, 2012 · Terminated
  90-5970-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 9 mm Height , Use With Plate 1,2 (5.5 MM un
• Z-1566-2012 · Feb 24, 2012 · Terminated
  90-5970-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 14mm Height , Use With Plate 1,2 Sterile R,
• 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-1590-2012 · Feb 24, 2012 · Terminated
  REF 90-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height , Steri
• Z-1605-2012 · Feb 24, 2012 · Terminated
  00-5976-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 12 mm Height , Steril

…and 52 more.