Prolong® NexGen® 5952-30-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024207981), received between Jul 6, 2022 and Nov 11, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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.

• 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 ↗
• 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 ↗
• InjuryJul 6, 2022Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE YEARS AND TWO AND A HALF MONTHS POST IMPLANTATION DUE TO INSTABILITY AND LIGAMENT LAXITY. THE INITIAL TIBIA, FEMUR, AND ARTICULAR SURFACE WERE REPLACED WITH A ROTATING HINGE KNEE DUE TO COMPROMISED COLLATERAL LIGAMENTS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Laxity

  MAUDE report 14935568 ↗

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-1569-2012 · Feb 24, 2012 · Terminated
  00-5972-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 9mm Height , ( 5.5MM under the Condyles) Ste
• Z-1552-2012 · Feb 24, 2012 · Terminated
  00-5970-02023, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23mm Height; Ster
• Z-1550-2012 · Feb 24, 2012 · Terminated
  00595202017, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw,
• 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-1604-2012 · Feb 24, 2012 · Terminated
  00-5976-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 10mm Height ,
• 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-1580-2012 · Feb 24, 2012 · Terminated
  00-5952-31-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 12mm Height , Sterile R
• 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-1600-2012 · Feb 24, 2012 · Terminated
  REF 90-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 14 mm Hei
• 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
• 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-1595-2012 · Feb 24, 2012 · Terminated
  REF 00-5970-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 17 mm Height , Steri
• 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

…and 52 more.