BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 56MM

    MDR report key: 2994129 · Received March 8, 2013

    Report

    Report Number
    1818910-2013-01458
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    December 16, 2009
    Report Date
    February 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUS EXAMINATION OF PRODUCT SHOWED ROOT CAUSE IS ATTRIBUTED TO OFF-LABEL USE. DEVICE HISTORY RECORDS AND STERILIZATION CERTIFICATIONS HAVE BEEN PREVIOUSLY REVIEWED FOR ALL ASSOCIATED PRODUCTS. REVIEW OF THE RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. ALTHOUGH THIS AND THE PREVIOUS INVESTIGATION COULD DRAW NO CONCLUSIONS REGARDING THE REPORTED EVENT, THE ROOT CAUSE IS ATTRIBUTED TO OFF-LABEL USE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    PREVIOUS EXAMINATION OF PRODUCT SHOWED ROOT CAUSE IS ATTRIBUTED TO OFF-LABEL USE. DEVICE HISTORY RECORDS AND STERILIZATION CERTIFICATIONS HAVE BEEN PREVIOUSLY REVIEWED FOR ALL ASSOCIATED PRODUCTS. REVIEW OF THE RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. ALTHOUGH THIS AND THE PREVIOUS INVESTIGATION COULD DRAW NO CONCLUSIONS REGARDING THE REPORTED EVENT, THE ROOT CAUSE IS ATTRIBUTED TO OFF-LABEL USE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT REVISED FOR ALVAL. THIS IS A CLINICAL PATIENT, CLINICAL REPORT STATES THE REASON FOR REVISION WAS BECAUSE OF DISLOCATION. **UPDATE** 2/7/2013- LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, ACETABULAR LOOSENING, TISSUE NECROSIS WITH METAL HYPERSENSITIVITY, AND JOINT EFFUSION. THE ACETABULAR CUP HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99105 PINNACLE SECTOR II CUP 56MM TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDICS INC US BW5CR1000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR