Prolong® NexGen® 5952-21-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024207912), received between Aug 23, 2021 and Aug 23, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, STIFFNESS, AND LIMITED RANGE OF MOTION THAT WAS UNRESOLVED WITH A MANIPULATION UNDER ANESTHESIA. THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 12356184 ↗

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-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-1598-2012 · Feb 24, 2012 · Terminated
  REF 90-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 10mm Heig
• 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-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-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-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-1603-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20mm Heig
• 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-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-1577-2012 · Feb 24, 2012 · Terminated
  00-5976-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 17mm Height , Sterile R, Rx ,Zimmer, In
• 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-1597-2012 · Feb 24, 2012 · Terminated
  REF 90-5970-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 9mm Heigh
• Z-1549-2012 · Feb 24, 2012 · Terminated
  00595202014, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 14mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, I

…and 52 more.