NexGen® Prolong® 00-5972-066-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024215207), received between Jun 2, 2021 and May 2, 2025 — classified as 5 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (K072281, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE ARE NO ALLEGATIONS AGAINST THIS DEVICE. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Insufficient Information

  MAUDE report 21950884 ↗
• InjuryApr 29, 2025Adverse 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: Adhesion(s); Arthrofibrosis; Loss of Range of Motion; Pain

  MAUDE report 21925742 ↗
• InjuryMar 30, 2023Fracture; Unstable; Device Dislodged or Dislocated; Fracture; Unstable; Device Dislodged or Dislocated

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

  Patient problems: Arthritis; Failure of Implant; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 16652320 ↗
• InjuryJun 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE. SURGEON RECENTLY (APPROXIMATELY 18 MONTHS POST PROCEDURE) DID AN ARTHROSCOPY ON THE SAME KNEE. NOT SURE WHY HE DID THE SCOPE, BUT DURING THE SCOPE PROCEDURE, HE NOTICED A SMALL PIECE OF POLY DEBRIS. THE SINGLE PIECE OF DEBRIS WAS REMOVED. THE PATIENT AND DR. HCP WOULD LIKE TO KNOW IF WE MAYBE HAD ANY REPORTS OF THIS PARTICULAR LOT OF PATELLAS. THE PATELLA WASN'T REMOVED FROM THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687023 ↗
• InjuryJun 2, 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; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 11923922 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072281, 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