BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 1984361 · Received January 27, 2011

    Report

    Report Number
    1818910-2011-01196
    Event Type
    Injury
    Date Received
    January 27, 2011
    Report Date
    March 27, 2026
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP 3 IS BEING SUBMITTED TO FILL THE GAP IN REPORT SEQUENCE NUMBERS.

    Additional Manufacturer Narrative · 0

    THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP 4 IS BEING SUBMITTED TO FILL THE GAP IN REPORT SEQUENCE NUMBERS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: D6. UPDATE 8/16/12 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIEDDOI INFORMATION FOR THE RIGHT HIP. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP 2 IS BEING SUBMITTED TO FILL THE GAP IN REPORT SEQUENCE NUMBERS.

    Additional Manufacturer Narrative · 0

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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 AUGUST OF 2010 FOLLOWING AN HHE (HEALTH HAZARD EVALUATION). FURTHER ANALYSIS REGARDING THE ASR PRODUCT FAMILY WILL BE DOCUMENTED, AS DETERMINED PERTINENT, IN WWCAPA 00777 AND 00780. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: BLOOD SPECIMENS TAKEN ON (B)(6) 2010, TESTED BY (B)(6) AND REPORTED ON (B)(6) 2010, REVEAL THAT THE PT HAS AN ABNORMALLY HIGH CHROMIUM LEVEL OF 4.6 MCG/1 (REFERENCE RANGE 1.4 OR LESS) AND AN ABNORMALLY HIGH COBALT LEVEL OF 6.5 MCG11 (REFERENCE RANGE OF 1.8 OR LESS). THESE LEVELS OF TOXICITY ARE A DIRECT RESULT OF METALLOSIS PRODUCED BY THE ASR XL ACETABULAR SYSTEMS IMPLANTED INTO HER LEFT AND RIGHT HIPS. IN ADDITION, BOTH HIP SOCKETS HAVE LOOSENED. DUE TO THE HIGH LEVELS OF TOXICITY AND THE LOOSENING IN THE HIP JOINTS, IN ALL PROBABILITY BOTH ARTIFICIAL HIPS WILL HAVE TO BE REMOVED AND REPLACED IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625410 ASR ACETABULAR CUPS 48 PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) KWA DEPUY INTERNATIONAL, LTD. NA 2294234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention