BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOFIT ALLOCLAS SHELL 52/II

    MDR report key: 23175154 · Received September 29, 2025

    Report

    Report Number
    0009613350-2025-00747
    Event Type
    Injury
    Date Received
    September 29, 2025
    Report Date
    March 26, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. DURAL ALPHA INSERT NEUTR II/32 ITEM# 0100013409 LOT# 3230479. BIOLOX DELTA HEAD 12/14 32X0 ITEM# 00877503202 LOT# 3232823. AVENIR MULLER STEM 5 STANDARD ITEM# 0106010005 LOT# 3218379. G2. REPORT SOURCE: GERMANY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A3A; B5; B6; B7; D2A; D2B; D8; G1; G3; H1; H6. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL HIP PROCEDURE. AFTER A WEEK OF REHAB, THERE WAS A LOUD SQUEAKING NOISE THAT WAS AUDIBLE EVEN TO OUTSIDERS. THIS CHANGED TO A CRACKING NOISE IN THE FOLLOWING DAYS AND UNDERWENT A REVISION SURGERY ON UNKNOWN DATE. THE FIRST X-RAY SHOWED THAT THE INLAY IN THE HIP SOCKET HAD SHIFTED. THIS WAS ALSO CONFIRMED BY A CT SCAN. BOTH HEADS (BALL AND INLAY) HAVE NOW BEEN REPLACED. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478321 ALLOFIT ALLOCLAS SHELL 52/II PROSTHESIS, HIP LZO ZIMMER GMBH 3240921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.