BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL MODULAR ACETABULAR SHELL

    MDR report key: 2013368 · Received March 8, 2011

    Report

    Report Number
    1822565-2011-00505
    Event Type
    Injury
    Date Received
    March 8, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: INFO REGARDING THE ORIGIN OF THE PAIN, X-RAYS, SURGICAL NOTES, PT DEMOGRAPHICS, ETC. WAS NOT PROVIDED FOR AN ANALYSIS OF THE ALLEGED PAIN. IT IS UNK HOW LONG THE DEVICE HAS BEEN IN VIVO. THE DEVICE WAS NOT RETURNED FOR REVIEW. WITH THE INFO PROVIDED REGARDING THE PT'S CONDITION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, 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 IS REPORTED THAT THE PT WAS PRESENTING WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL MODULAR ACETABULAR SHELL LPH ZIMMER, INC. 60104650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other