BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HUMERAL TRIAL INSTRUMENT

    MDR report key: 2031156 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00701
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENT IS UNK. THE INCLUDED NOTES STATE THAT THE SURGEON USED POWER DURING REAMING AND DID NOT RE-REAM AFTER RESECTION OF THE HUMERAL HEAD. THESE PRACTICES ARE NOT INLINE WITH ZIMMER'S SURGICAL TECHNIQUE. IT IS STRONGLY RECOMMENDED THAT THE SURGICAL TECHNIQUE IS FOLLOWED TO ENSURE PROPER FIT OF BOTH THE PROVISIONALS AND FINAL IMPLANTS. THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED WITH CERTAINTY. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SHOULDER ARTHROPLASTY, THE TRIAL STEM BECAME STUCK IN THE HUMERAL CANAL. AN OSTEOTOMY WAS PERFORMED TO REMOVE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER HUMERAL TRIAL INSTRUMENT SHOULDER INSTRUMENT LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention