BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H

    MDR report key: 7612978 · Received June 19, 2018

    Report

    Report Number
    0009613350-2018-00641
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    August 7, 2015
    Report Date
    June 19, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K053536. THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. NO FURTHER INVESTIGATION REQUIRED AS THIS ISSUE IS KNOWN AND ADDRESSED IN (B)(4) (ERROR PATTERN: POTENTIAL EARLY REVISION OF THE ACETABULAR COMPONENT DUE TO LOOSENING, IMPLANT MIGRATION OR UNRESOLVED PAIN, HIGHER ION RELEASE). AT LEAST ONE OF THESE ERROR PATTERNS IS OBSERVED IN THIS EVENT. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, OR ANY EXTRA DEMAND BE REQUESTED, WE WILL REEVALUATE THE CASE. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY FIVE YEARS POST IMPLANTATION DUE TO PAIN, METALLOSIS, AND LIMITED RANGE OF MOTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458322 METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H KWA ZIMMER GMBH N/A 2462651

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R FITMORE HIP STEM, ITEM# 0100551205, LOT# 2471269| METASUL HEAD ADAPTER, ITEM# 01.00185.145. LOT# 244| METASUL HEAD, ITEM# 01.00181.420, LOT# 2449633