NexGen® 5880-14-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024199132), received between Dec 30, 2020 and Jun 23, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY. APPROXIMATELY SEVEN YEARS AFTER, THE PATIENT UNDERWENT A REVISION DUE TO PERI-PROSTHETIC FEMUR FRACTURE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Periprosthetic fracture

  MAUDE report 25593208 ↗
• InjuryDec 16, 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: Insufficient Information

  MAUDE report 23815614 ↗
• InjuryDec 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. AFTER APPROXIMATELY 12 YEARS, THEY HAD A REVISION DUE TO UNKNOWN REASON. NO OPERATIVE RECORDS PROVIDED. THEN, ABOUT A YEAR LATER THE PATIENT HAD A RIGHT KNEE EXPLORATION OF EXTENSOR TENDON AND TWO YEARS LATER THE PATIENT UNDERWENT A 2ND REVISION FOR IMPLANT BREAKAGE OF THE HINGE PIN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23790425 ↗
• InjuryNov 25, 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: Joint Laxity; Loss of Range of Motion

  MAUDE report 23650638 ↗
• InjurySep 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Bone Fracture(s)

  MAUDE report 23061933 ↗
• InjuryFeb 12, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT WAS REVISED BECAUSE THERE WAS METAL DEBRIS. THE FEMUR WAS NOT SECURE TO THE STEM EXTENSION IT WAS ATTACHED TO. THE HCP DEDUCED THE SCREWS USED TO SECURE THE STEM EXTENSION TO THE FEMUR LOOSENED, OR WERE DAMAGED. THE FEMORAL AND STEM WERE REVISED FOR CAUSE.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 21364339 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Septic loosening

  MAUDE report 20903076 ↗
• InjuryJun 2, 2022Fracture; Fracture

  IT WAS REPORTED A CUSTOMER RECEIVED A RHK. APPROXIMATELY 3 YEARS POST IMPLANTATION THE HINGE WAS NOTED AS FRACTURED, IDENTIFIED BY X-RAY. DR. (B)(6) REMOVED THE HINGE AND REPLACED IT.

  Patient problems: Failure of Implant

  MAUDE report 14573446 ↗
• MalfunctionApr 19, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE SIZE DISPLAYED ON THE BOX FOR THE FEMORAL COMPONENT WAS DIFFERENT THAN THE ACTUAL SIZE OF THE IMPLANT PACKED IN THE BOX. THE SIZE DISPLAYED ON THE LABEL WAS C AND THE ACTUAL IMPLANT WAS D. THE SIZE D FEMORAL COMPONENT WAS USED AS THERE WAS NO OTHERS IN STOCK. ANOTHER TIBIAL COMPONENT WAS USED IN ORDER TO BE COMPATIBLE WITH THE FEMUR. WHEN THE SURGEON OPENED THE C BLOCK AND STEM TO ASSEMBLE THE FEMORAL COMPONENT, IT WAS DISCARDED AS THE FEMUR WAS CHANGED FROM A SIZE C TO D. THERE WAS A 30 MINUTE SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140447 ↗
• InjuryDec 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Pain

  MAUDE report 11096675 ↗

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-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.
• 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.