BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 3160739 · Received June 10, 2013

    Report

    Report Number
    1818910-2013-18546
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 20, 2013
    Report Date
    September 25, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: PAIN AND LOOSENING; METALLOSIS; SEROSANGUINEOUS FLUID; SIGNIFICANT FIBROSIS AND A PSEUDOCAPSULE WITH METALLOSIS FINDINGS; SOME MINOR BONE DEFECTS. FEMORAL HEAD ADDED TO COMPLAINT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO CUP LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261183 ASR ACETABULAR CUPS 54 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2815283

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention