BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2061146 · Received January 25, 2011

    Report

    Report Number
    1818910-2011-01037
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 29, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A LOT SPECIFIC COMPLAINT DATABASE SEARCH AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE NECESSARY LOT AND PRODUCT CODES WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH THE ROOT CAUSE CANNOT BE DETERMINED, IT IS KNOWN THAT THE ASR PLATFORM WAS VOLUNTARILY RECALLED IN (B)(4) 2010 FOLLOWING AN HHE (HEALTH HAZARD EVALUATION). FURTHER ANALYSIS REGARDING THE ASR PRODUCT FAMILY WILL BE DOCUMENTED, AS DETERMINED PERTINENT, IN (B)(4) AND (B)(4). BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT STATES: DEPUY ASR TOTAL HIP ARTHROPLASTY SYSTEM HAD TO BE EXPLANTED. THE IMPLANT WAS CAUSING THE PT GREAT PAIN AND REVISION SURGERY WAS REQUIRED. THE DEPUY ASR IS PART OF A CURRENT RECALL. THE PT ORIGINALLY UNDERWENT THA DUE TO OSTEOARTHRITIS OF HIP. THE ORIGINAL ACETABULAR COMPONENT INCLUDED A ZIMMER TRABECULAR METAL CUP (SZ 62) WITH TWO SCREWS AND A 40 MM POLYETHYLENE LINER. THE ORIGINAL FEMORAL COMPONENT WAS A 40 MM X PLUS 8.5 MM NECK BIOLOX HEAD WITH A METAL SLEEVE. PT IS A (B)(6) MALE WHO HAD A DEPUY ASR HIP PLACED APPROX TWO YEARS AGO. HE DID WELL UNTIL ABOUT FOUR MONTHS AGO WHEN HE BEGAN TO DEVELOP THROBBING PAIN IN THE THIGH WITH ACTIVITY AND AT REST. HE HAD POSITIVE METAL ION LEVELS IN HIS BLOOD. HE CONSENTED TO HAVE REVISION SURGERY FOR THE RECALLED ASR ACETABULAR COMPONENT. DURING SURGERY, A LARGE PSEUDOCAPSULE WAS FOUND TO BE POSTERIORLY COMMUNICATING WITH THE JOINT. THIS PSEUDOCAPSULE WAS ALMOST COMPLETELY AVASCULAR. THERE WAS NO ERYTHEMA AROUND THE HIP AT ALL AND NO HYPEREMIA WITH THE SURGICAL APPROACH. THE FIBROUS TISSUE FORMING THE PSEUDOCAPSULE WAS EXTREMELY DENSE. IT MEASURED APPROX 1.5 CM IN THICKNESS AND HAD TO BE EXCISED. THE REVISION SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention