BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 2

    MDR report key: 4140654 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03756
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    April 4, 2014
    Report Date
    August 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # MMH-9988-0050, LOT # FM060371, DESCRIPTION: MITCH TRH MD HD SZ 50+0, MANUFACTURER: DEPUY; CAT # MAC-9988-5056, LOT # FM099921, DESCRIPTION: STD MITCH TRH CP SZ 50/56, MANUFACTURER: DEPUY; CAT # 0939-0-112, LOT # L4849, DESCRIPTION: EXETER 2.5 I M PLUG 12MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REVISION INVOLVING AN EXETER V40 STEM 44MM NO 2 WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED RECORDS INDICATED THAT A CLEAR RELATIONSHIP BETWEEN THE SUSPECTED IMPLANTED DEVICES, EITHER STEM OR MOM MITCH TRH, AND THE INDICATION FOR REVISION IS AT LEAST QUESTIONABLE AND NOT SUPPORTED BY ANY EVIDENCE AVAILABLE SO FAR UNLESS FUTURE PROOF OF CONTRARY. BASED ON CURRENT INFORMATION THERE IS NO EVIDENCE FOR ANY DEVICE-RELATED ASPECT REGARDING THE EXETER STEM AND MOST PROBABLY ALSO NOT FOR THE MITCH TRH DEVICES. WITHOUT FURTHER INFORMATION IT WOULD ALSO BE DIFFICULT TO DIFFERENTIATE BETWEEN PROBLEMS ORIGINATING IN THE PATIENT¿S LEFT OR RIGHT HIP ALTHOUGH THE IMPLANTED COMPONENTS ARE SIMILAR. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SAME LOT NUMBER. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NOT ENOUGH INFORMATION WAS PROVIDED FOR REVIEW. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    REVISION OF LEFT MITCH TRH IMPLANT.

    Description of Event or Problem · 1

    REVISION OF LEFT MITCH TRH IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619733 EXETER V40 STEM 44MM NO 2 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G2904253

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention