NexGen® 5881-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024199958), received between Jun 21, 2022 and Mar 16, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Fracture

  IT WAS REPORTED THAT A SCREWDRIVER FRACTURED WHILE TIGHTENING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606163 ↗
• MalfunctionFeb 25, 2026Fracture

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE HEX SCREW DRIVER HEAD FRACTURED WHILE TORQUING THE BOLT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445298 ↗
• MalfunctionJan 6, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981022 ↗
• MalfunctionFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A SCREWDRIVER FRACTURED DURING SURGERY. THE FRACTURED PIECE WAS RECOVERED BY THE SURGEON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399653 ↗
• MalfunctionAug 7, 2024Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 19927755 ↗
• MalfunctionMar 6, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848773 ↗
• MalfunctionFeb 27, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789808 ↗
• MalfunctionDec 18, 2023Fracture; Fracture

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18348277 ↗
• MalfunctionDec 5, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266291 ↗
• MalfunctionOct 31, 2023Fracture; Fracture

  IT WAS REPORTED THE BROKEN SCREW DRIVER WAS FOUND IN THE LOANER KIT BY THE WAREHOUSE TEAM DURING CHECK IN, AFTER THE PRODUCRT WAS RECEIVED. THE CUSTOMER'S STERILIZATION SERVICE CONFIRMED BY TELEPHONE THE LOANER KIT WAS USED FOR A SURGERY, THAT THE INSTRUMENT WAS RETURNED BACK TO ZIMMER BIOMET IN THE KIT, BUT NO IMPACT ON PATIENT OR NO INCIDENT DURING THE SURGERY WAS REPORTED TO THE SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038388 ↗
• MalfunctionOct 31, 2023Fracture; Fracture

  IT WAS REPORTED THE BROKEN SCREW DRIVER WAS FOUND IN THE LOANER KIT BY THE WAREHOUSE TEAM DURING CHECK IN, AFTER THE PRODUCT WAS RECEIVED. THE CUSTOMER'S STERILIZATION SERVICE CONFIRMED BY TELEPHONE THE LOANER KIT WAS USED FOR A SURGERY, THAT THE INSTRUMENT WAS RETURNED BACK TO ZIMMER BIOMET IN THE KIT, BUT NO IMPACT ON PATIENT OR NO INCIDENT DURING THE SURGERY WAS REPORTED TO THE SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038385 ↗
• MalfunctionAug 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE SURGEON WAS USING THE SCREWDRIVER WITH ITS TIP TO UNSCREW THE HINGE SCREW FROM THE PROSTHESIS IN A COUNTER-CLOCKWISE DIRECTION. AFTER THREE-FOURTHS OF A TURN, THE SCREWDRIVER JAMMED AND BROKE OFF INTO THE HINGE SCREW. IT WAS THEN NOT POSSIBLE TO REMOVE THE PROSTHESIS WITHOUT REMOVING THE HINGE. THIS RESULTED IN THE USE OF A LARGE NUMBER OF COMPLIMENTARY BOXES LEADING TO A RISK OF LACK OF MATERIAL FOR THE OTHER PATIENTS FOR THE DAY. IT ALSO INCREASED OPERATING TIME BY 2 HOURS. A DRILL BIT WAS USED TO REMOVE THE HINGE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640953 ↗
• InjuryAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION KNEE PROCEDURE, THE HEX DRIVER FRACTURED WHILE ATTEMPTING TO DECOUPLE THE KNEE PROSTHESIS. THE PROCEDURE WAS UNABLE TO BE COMPLETED AT THAT TIME. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15314666 ↗
• MalfunctionJun 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TORQUE WENCH TIP BROKE OFF WHEN TRYING TO LOOSEN THE PEG SO THE SURGEON HAD TO USE A BURR TO CUT OFF THE HINGE POST TO REMOVE THE WHOLE FEMUR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754731 ↗