Zimmer Biomet™ 89-8521-470-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00889024581722), received between Nov 16, 2023 and Feb 22, 2024 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (30 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WON'T CHARGE. UPON FURTHER EVALUATION, IT WAS FOUND THIS BATTERY GAVE ERROR CODE 85 AND HAD NO POWER DUE TO OVERHEAT. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757738 ↗
• MalfunctionFeb 12, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING EVALUATION AT THE REPAIR CENTER, IT WAS DISCOVERED THAT BATTERY DOES NOT HAVE POWER DUE TO OVERHEAT ISSUE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. NO MORE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684859 ↗
• MalfunctionFeb 8, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DOES NOT CHARGE DUE TO OVERHEATING. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667172 ↗
• MalfunctionFeb 2, 2024Overheating of Device; Battery Problem; Overheating of Device; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER DUE TO A STATE OF HEALTH AND OVERHEAT ISSUE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632164 ↗
• MalfunctionFeb 2, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING EVALUATION OF THE BATTERY AT THE REPAIR CENTER, IT WAS DISCOVERED THAT IT HAD NO POWER DUE TO AN OVERHEAT ISSUE. ALTHOUGH THIS EVENT OCCURRED OUT OF SURGERY, IT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. NO MORE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629601 ↗
• MalfunctionFeb 1, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER DUE TO OVERHEATING. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622028 ↗
• MalfunctionFeb 1, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER DUE TO OVERHEATING. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621133 ↗
• MalfunctionJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER DUE TO OVERHEATING. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613549 ↗
• MalfunctionJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE STERILISABLE BATTERY DOES NOT HAVE POWER DUE TO AN OVERHEAT ISSUE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613233 ↗
• MalfunctionJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE STERILISABLE BATTERY DOES NOT HAVE POWER DUE TO AN OVERHEAT ISSUE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613220 ↗
• MalfunctionJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE STERILISABLE BATTERY DOES NOT HAVE POWER DUE TO AN OVERHEAT ISSUE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613212 ↗
• MalfunctionJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE STERILISABLE BATTERY DOES NOT HAVE POWER DUE TO AN OVERHEAT ISSUE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613196 ↗
• MalfunctionJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE STERILISABLE BATTERY DOES NOT HAVE POWER DUE TO OVERHEAT ISSUE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613184 ↗
• MalfunctionJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE STERILISABLE BATTERY DOES NOT HAVE POWER DUE TO A OVERHEAT ISSUE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613178 ↗
• MalfunctionJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER DUE TO OVERHEATING. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612373 ↗
• MalfunctionJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING THE SURGERY, THE STERILIZABLE BATTERY WAS FOUND TO HAVE NO POWER DUE TO AN OVERHEATING ISSUE. THERE WAS A 5-MINUTE DELAY IN SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612308 ↗
• MalfunctionJan 31, 2024Overheating of Device; Battery Problem; Overheating of Device; Battery Problem

  IT WAS REPORTED THAT DURING EVALUATION OF THE BATTERY IN A REPAIR CENTER, IT WAS NOTICED THAT IT DOES NOT HAVE POWER DUE TO OVERHEAT. ALTHOUGH THIS EVENT OCCURED OUT OF SURGERY, IT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. NO MORE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612047 ↗
• MalfunctionJan 25, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT BATTERY DISPLAYS AN ERROR DUE TO AN OVERHEAT ISSUE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578609 ↗
• MalfunctionJan 24, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT STERILIZABLE BATTERY WAS DEFECTIVE DUE TO OVERHEAT ISSUE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569487 ↗
• MalfunctionJan 24, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT STERILIZABLE BATTERY WAS DEFECTIVE DUE TO OVERHEAT ISSUE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569480 ↗
• MalfunctionJan 23, 2024Overheating of Device; Battery Problem; Overheating of Device; Battery Problem

  IT WAS REPORTED THAT DURING A CHECK AT THE REPAIR CENTRE, IT WAS DISCOVERED THAT THE BATTERY DID NOT HAVE POWER DUE TO OVERHEATING. ALTHOUGH THIS EVENT OCCURED OUT OF SURGERY, IT IS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. NO MORE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18561881 ↗
• MalfunctionJan 22, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE DID NOT HAVE POWER DUE TO OVERHEATING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551060 ↗
• MalfunctionJan 19, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OVERHEATED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541873 ↗
• MalfunctionJan 18, 2024Overheating of Device; Battery Problem; Overheating of Device; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DID NOT WORK AND SHOWED AN ERROR WHEN PLACED IN THE CHARGER. DURING EVALUATION AT THE REPAIR CENTER IT TURNED OUT THAT THIS BATTERY DID NOT HAVE POWER DUE TO OVERHEAT. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532805 ↗
• MalfunctionJan 12, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT UPON RECEIPT, THE DEVICE DOES NOT HAVE POWER DUE TO OVERHEAT AND ERROR 85. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501174 ↗