Zimmer Biomet™ 89-8510-440-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024355156), received between Jan 26, 2018 and Feb 10, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE BATTERY SHOWED SIGNS OF MELTING PRIOR TO SURGERY. NO PATIENT INVOLVEMENT WAS REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342927 ↗
• MalfunctionFeb 21, 2023Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16407167 ↗
• MalfunctionFeb 21, 2023Mechanical Problem; Mechanical Problem

  UPON FURTHER ASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED AS THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. GIVEN THIS INFORMATION, THIS MEDWATCH REPORT WILL BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406891 ↗
• MalfunctionJan 31, 2023Explosion; Explosion

  IT WAS REPORTED THAT A BATTERY WAS RECEIVED ERUPTED. THIS WAS SEEN DURING PRODUCT CHECKING. NO SURGERY, HOSPITAL OR PATIENT INVOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270191 ↗
• InjuryDec 8, 2022Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  IT WAS REPORTED THAT A DEFECT WAS DISCOVERED WHEN THE MACHINE WAS CHECKED AT THE BEGINNING OF THE OPERATION. DESPITE THE REPLACEMENT OF THE BATTERY AND THE BATTERY HOUSING, THE MACHINE DID NOT WORK AND SINCE NO MORE MACHINES WERE AVAILABLE THAT DAY, THE OPERATION HAD TO BE CANCELLED. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND HAD TO BE DISCHARGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15938343 ↗
• InjuryDec 8, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT A DEFECT WAS DISCOVERED WHEN THE MACHINE WAS CHECKED AT THE BEGINNING OF THE OPERATION. DESPITE THE REPLACEMENT OF THE BATTERY AND THE BATTERY HOUSING, THE MACHINE DID NOT WORK AND SINCE NO MORE MACHINES WERE AVAILABLE THAT DAY, THE OPERATION HAD TO BE CANCELLED. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND HAD TO BE DISCHARGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15937805 ↗
• MalfunctionJun 29, 2018Degraded; Melted; Device Emits Odor; Overheating of Device; Battery Problem; Overheating of Device

  IT WAS REPORTED THAT THE BATTERY FOR ASEPTIC TRANSFER KIT, SERIAL NUMBER (B)(4), PART NUMBER 89-8510-440-20 DISCHARGED ELECTROLYTE AND WAS DEGRADED. THE BATTERY WAS DISCOVERED PACKAGED IN A CARDBOARD BOX IN A NURSE ROOM WITH BURNING SMELL. THERE WERE NO OTHER PRODUCTS OF THE SAME TYPE NEARBY. ACCORDING TO THE PICTURE PROVIDED, THE BATTERY IS PARTIALLY MELTED. NO SURGERY WAS INVOLVED. THERE WAS NO HARM OR INJURY TO PATIENT/OPERATOR REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 7649787 ↗
• MalfunctionJan 26, 2018Melted; Overheating of Device; Smoking; Overheating of Device

  IT WAS REPORTED THAT AFTER ABOUT 20 MINUTES OF CHARGING ON COMPACT BATTERY CHARGER SERIAL NUMBER (B)(4), THE BATTERY FOR ASEPTIC TRANSFER KIT SERIAL NUMBER (B)(4), PART NUMBER 89-8510-440-20 HEATED. THE STAFF SAW THAT THE BATTERY WAS STARTING TO PRODUCE SMOKE AND SWITCHED OFF THE BATTERY CHARGER. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, A PART OF THE HOUSING MELTED. NO SURGERY WAS INVOLVED. THERE WAS NO HARM OR INJURY TO PATIENT/OPERATOR REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 7220945 ↗