NexGen® 5880-20-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024199187), received between Sep 30, 2019 and Sep 9, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K013385, 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.

• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE PATIENT IS AN EXTREMELY SMALL FEMALE WITH POLIO WHO HAS THE SMALLEST RHK SIZES AVAILABLE. BECAUSE OF HER CONDITION, SHE HAS EXTREMELY LIMITED RANGE OF MOTION AND WILL REQUIRE EITHER A REVISION TO A DISTAL FEMORAL REPLACEMENT OR PROXIMAL TIBIAL REPLACEMENT IN ORDER TO INCREASE HER JOINT SPACE AND THEREFORE GAIN MOBILITY AND FUNCTION IN HER KNEE. SHE HAS NO OTHER ADVERSE SYMPTOMS OTHER THAN LIMITED MOBILITY AND RANGE OF MOTION.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain

  MAUDE report 23008952 ↗
• MalfunctionJun 6, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING A REVISION PROCEDURE, WENT TO OPEN IMPLANT DELIVERED FROM CENTRAL INVENTORY AND WHEN PACKAGE WAS OPENED IT WAS DAMAGED AND THE LOCKING POST WAS OUTSIDE OF STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604922 ↗
• InjurySep 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Pain

  MAUDE report 9136168 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013385, 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-1448-04 · Aug 3, 2004 · Terminated
  Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
• Z-1447-04 · Aug 3, 2004 · Terminated
  Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, for cemented use only; Cat. No. 5880-02-02.