Zimmer Biomet™ 89-8522-450-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024521315), received between Nov 8, 2023 and Feb 18, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MOTOR STOPPED WORKING DURING SURGERY WITH THE RECIPROCATING SAW ATTACHMENT ON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392920 ↗
• MalfunctionFeb 12, 2025Mechanical Jam; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362842 ↗
• MalfunctionFeb 10, 2025Explosion; Explosion

  IT WAS REPORTED THAT THE RECIPROCATING SAW ATTACH EXPLODED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 21341924 ↗
• MalfunctionDec 20, 2024Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986930 ↗
• MalfunctionDec 19, 2024Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20974011 ↗
• MalfunctionNov 7, 2024Mechanical Jam; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628715 ↗
• MalfunctionOct 2, 2024Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350992 ↗
• MalfunctionAug 27, 2024Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT THE RECIPROCATING SAW SUDDENLY STOPPED DURING PROCEDURE. ANOTHER SAW WAS USED TO FINISH SURGERY. 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 20074362 ↗
• MalfunctionJul 29, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE INITIAL SURGERY, THE RECIPROCATING SAW ATTACHMENT STOPPED. 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. 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 19848986 ↗
• MalfunctionNov 8, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PIN COLLET WOULD NOT HOLD THE PIN. 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 18090373 ↗