Prolong® NexGen® 5952-30-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024207967), received between Jul 6, 2021 and Jul 13, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING SEVERE PAIN IN THE KNEE SEVERAL YEARS AFTER A RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT REPORTED THAT THE KNEE FELT WARM TO THE TOUCH AND THERE IS A BURNING, STABBING CONSTANT PAIN THAT GETS WORSE WHEN SHE SITS OR STANDS. THE PATIENT HAD X-RAYS DONE WHICH SHOWED NOTHING WRONG. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15005195 ↗
• InjurySep 21, 2021Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE ARTHROPLASTY. THE PATIENT REPORTED PAIN AND INSTABILITY SINCE PRIMARY SURGERY. NO EVENT ASSOCIATED WITH THE ONSET OF SYMPTOMS. PATIENT WAS REVISED APPROXIMATELY ONE YEAR 10 MONTHS POST PROCEDURE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12506320 ↗
• InjurySep 15, 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: Insufficient Information

  MAUDE report 12474581 ↗
• InjuryJul 6, 2021Unstable; Unstable

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION KNEE ARTHROPLASTY APPROXIMATELY 18 MONTHS¿ POST IMPLANTATION DUE TO INSTABILITY AND HYPEREXTENSION. THE ARTICULAR SURFACE WAS REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Hyperextension

  MAUDE report 12120515 ↗

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-1553-2012 · Feb 24, 2012 · Terminated
  90595202012, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 12 mm Height; Steri
• 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-1575-2012 · Feb 24, 2012 · Terminated
  00-5976-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 10mm Height , Sterile R, Rx ,Zimmer, In
• 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-1555-2012 · Feb 24, 2012 · Terminated
  90595202017, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 17 mm Height; Ster
• Z-1610-2012 · Feb 24, 2012 · Terminated
  00-5972-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 23 mm Height , Sterile R
• 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-1609-2012 · Feb 24, 2012 · Terminated
  00-5970-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Striped Yellow 23 mm Height , Sterile R, Rx ,
• Z-1547-2012 · Feb 24, 2012 · Terminated
  00595202010, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 10mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, I
• Z-1593-2012 · Feb 24, 2012 · Terminated
  REF 00-5970-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height , Steril
• Z-1554-2012 · Feb 24, 2012 · Terminated
  00-5976-020-23 NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23 mm Height; St
• 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-1611-2012 · Feb 24, 2012 · Terminated
  00-5976-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 23 mm Height , Steril

…and 52 more.