BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 40 +1.5

    MDR report key: 2992855 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-13388
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    July 31, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    UDI-DI
    10603295032977
    PMA / PMN Number
    K082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED FOR THE FEMORAL HEAD AND METAL LINER. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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

    THE 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

    PRODUCT COMPLAINT # (B)(4). UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-000224192 (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    (B)(4). ADDED: (AGE).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFF ALLEGES METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, MEDICAL RECORDS PROVIDED IMPLANT RECORD.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFF ALLEGES METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, MEDICAL RECORDS PROVIDED IMPLANT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97668 ASPHERE M SPEC 12/14 40 +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS KWA DEPUY ORTHOPAEDICS INC US 2961098 10603295032977
    97691 ASPHERE M SPEC 12/14 40 +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS KWA DEPUY ORTHOPAEDICS INC US 2961098 10603295032977

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Other