BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL HIP BALL 28MM +5

    MDR report key: 2934900 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-11660
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. ? REG. # 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK860701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF PROVIDED MEDICAL RECORDS BY THE DEPUY LEGAL NURSE FINDS THE PATIENT IS AN (B)(6) YO OBESE FEMALE THAT HAD A REVISION ON (B)(6) 2013 TO ADDRESS CHRONIC DISLOCATIONS. AN UNDATED RADIOGRAPH CONFIRMS THE COMPLAINT SHOWING A RIGHT DISLOCATED HIP WITH THE ACETABULAR SHELL IN A VERTICAL POSITION. THERE IS NOT AN EARLIER RADIOGRAPH TO COMPARE TO, BUT SHE ASSUMED THIS WAS NOT THE ORIGINAL POSITION OF THE CUP AND THAT IT WAS LOOSE AND SHIFTED WITHIN THE ACETABULUM . THERE IS A REVISION OPERATIVE NOTE STATING THE SIZE 50 MM ACETABULAR SHELL WAS EXCHANGED FOR ANOTHER ACETABULAR SHELL SECURED WITH 3 SCREWS AND A CONSTRAINED LINER. THERE IS A POST-REVISION RADIOGRAPH SHOWING THE NEW IMPLANTS IN ANATOMIC POSITION. NO OTHER MEDICAL RECORDS OR INFORMATION WAS PROVIDED, SO IT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED THAT THE COMPLAINT IS PRODUCT RELATED. IT IS STATED IN WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT CAN ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS ALL TOTAL HIP ARTHROPLASTY HAS A RISK OF FAILURE AND THE RISKS FOR AN INDIVIDUAL ARE AN UNPREDICTABLE COMBINATION OF PATIENT, SURGICAL PROCESS AND SURGICAL PROCEDURE AND DEVICE RELATED INTERACTIONS. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40535 TOTAL HIP BALL 28MM +5 FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. ? REG. # 8010379 1089752

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention