ZIMMER 2443-00-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295124597), received between Sep 29, 2017 and Jul 16, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

• MalfunctionJul 16, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE ADAPTOR IS WOBBLING AND NOT FITTING TIGHT FOR INSTRUMENTS. THERE WAS NO SURGICAL DELAY .

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749739 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT THE ZIMMER HUDSON TO HUDSON ADAPTER BROKE DURING SURGERY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062340 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT THE ZIMMER HUDSON TO HUDSON ADAPTR BROKE DURING SURGERY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062329 ↗
• MalfunctionMar 15, 2021Break; Break

  DURING THR, THE SURGEON TRIED TO ATTACH THE "HUDSON" ADAPTOR TO THE POWER TOOL AND THE TOP EDGE GOT BROKEN. THE PATIENT DIDN'T HARM.

  Patient problems: Insufficient Information

  MAUDE report 11489380 ↗
• MalfunctionMar 5, 2021Mechanical Jam; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED STATING THAT "IT DOES NOT APPEAR THIS IS ZIMMER BIOMET PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424012 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT. TWO INSTRUMENTS BROKE DURING THE CASE. WE HAD BACK UP REPLACEMENTS AVAILABLE AND THERE WERE NO DELAYS OR PROBLEMS BECAUSE OF IT IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012795 ↗
• MalfunctionJan 24, 2020Crack; Crack

  IT WAS REPORTED THAT THE ATTACHMENT WAS CRACKED WHILE REAMING THE FEMORAL CANAL. NO INJURY TO PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9629236 ↗
• MalfunctionJul 30, 2019Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  INSTRUMENT IS WORN AND NEEDS TO BE REPLACED. IT IS NO LONGER HOLDING REAMERS PROPERLY. NOTHING BROKEN, NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY . ONE IMPACTED, ONE NEEDING REPLACEMENT. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841408 ↗
• MalfunctionApr 11, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  HUDSON ADAPTOR WOULD NOT RELEASE ANY ATTACHMENT THAT WAS USED WITH THE ADAPTOR. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506152 ↗
• MalfunctionSep 17, 2018Break; Break

  IT WAS REPORTED THAT THE ADAPTER RETURNED TO THE OFFICE WITH SMALL CHIPS ON THE BOTTOM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7880807 ↗
• MalfunctionAug 22, 2018Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  THE SURGEON WAS REAMING THE FEMUR DURING A TOTAL HIP AND THE HUDSON ADAPTOR BENT AND PRODUCED A SMALL CRACK. THEY OPENED ANOTHER ONE TO CONTINUE. INSTRUMENT NEEDS TO BE REPLACED. NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. ONE IMPACTED, ONE NEEDING REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7805134 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED THAT THE FOLLOWING PIECES WERE FOUND WHEN SETTING UP FOR A CASE. 2 ATTUNE RP PS ARTIC SURF SZ7 (CIRCULAR SPRINGS ON THESE ARE DAMAGED), ZIMMER HUDSON TO HUDSON ADAPTOR, MBT REV TIBIAL VIEW PLATE SZ1 (BROKEN IN HALF), AND AN ATTUNE FEMORAL IMPACTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761701 ↗
• MalfunctionNov 14, 2017Break; Break

  IT WAS REPORTED THAT AFTER REAMING WITH THE SUMMIT TAPERED REAMERS, THE REAMER HANDLES WOULD DISCONNECT FROM THE HUDSON ADAPTOR AND WOULD KEEP PULLING THE REAMER OUT OF THE FEMORAL CANAL. UPON INSPECTION DURING THE PROCEDURE, THE SCRUB NURSE FOUND THAT THE ADAPTOR LOOKED TO BE BENT AT THE POINT OF CONNECTION. AFTER TERMINALLY STERILIZED BY MDR, THEY COULDN'T FIND A MAJOR BEND OR ANY DAMAGE, BUT THE ADAPTOR DID NOT SEEM TO HOLD THE CONNECTION WELL. CONSIDERING THAT THE REAMER HANDLES WERE NOT DAMAGED WHATSOEVER, THEY DECIDED THAT THE PROBLEM MUST BE WITH THE HUDSON ADAPTOR AND THAT IT SHOULD BE REPLACED IN ORDER TO AVOID ANY SUCH PROBLEM AGAIN.

  Patient problems: No Information

  MAUDE report 7029517 ↗
• MalfunctionSep 29, 2017Break; Break

  IT WAS REPORTED THAT WHILE CLEANING UP ON (B)(6) 2017 FROM CASES ON (B)(6) 2017, IT WAS DISCOVERED THAT THE MODIFIED HUDSON ADAPTER WAS BROKEN.

  Patient problems: No Information

  MAUDE report 6905027 ↗