BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 62

    MDR report key: 2230351 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-16958
    Event Type
    Injury
    Date Received
    September 1, 2011
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2007, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE. HE HAS EXPERIENCED PAIN, PHYSICAL INJURY, BODILY IMPAIRMENT, DISFIGUREMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL ANGUISH, AND EMOTIONAL DISTRESS. IT IS REASONABLY CERTAIN THAT PATIENT WILL HAVE TO UNDERGO REVISION SURGERY. DOI: (B)(6) 2007 - DOR: UNK (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6) 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. WWCAPA (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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6), 2007, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE. HE HAS EXPERIENCED PAIN, PHYSICAL INJURY, BODILY IMPAIRMENT, DISFIGUREMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL ANGUISH, AND EMOTIONAL DISTRESS. IT IS REASONABLY CERTAIN THAT PATIENT WILL HAVE TO UNDERGO REVISION SURGERY.

    Description of Event or Problem · 1

    UPDATE AUG 2, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, AND IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, OPERATIVE FINDINGS STATED THAT THERE WAS EVIDENCE OF METALLOSIS IN THE SOFT TISSUES AND HIP CAPSULE AND TRUNNIONOSIS. THIS COMPLAINT WAS UPDATED ON AUG 16, 2017.

    Description of Event or Problem · 1

    UPDATE JUL 13, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED DUE TO PAINFUL RIGHT TOTAL HIP REPLACEMENT WITH METAL ON METAL FAILURE. REVISION NOTES REPORTED FLUID WITH BROWN STAINING WITH PARTICULATE DEBRIS, DARK STAINING OF THE SYNOVIUM, BLACK CORROSION ON THE TRUNNION, AND A SMALL AREA OF OSTEOLYSIS SUPERIORLY RIGHT ON THE RIM. THIS COMPLAINT WAS UPDATED ON JUL 21, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 62 ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2147435

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention