BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADM RIM IMPACTOR TIP

    MDR report key: 4295514 · Received December 3, 2014

    Report

    Report Number
    0002249697-2014-04506
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 6, 2014
    Report Date
    November 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING AN ADM IMPACTOR WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: A MATERIAL ANALYSIS REPORT (MAR) CONCLUDED THAT THE FRACTURE WAS CONSISTENT WITH THE APPLICATION OF OFF-AXIS OVERLOAD STRESSES. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE FRACTURE SURFACES EXAMINED DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER COMPLAINTS FOR THE REPORTED LOT. CONCLUSIONS: THIS EVENT WAS PREVIOUSLY INVESTIGATED UNDER INVESTIGATION AND CAPA.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY SURGERY, WHEN DR. WAS IMPACTING THE ADM CUP, THE CUP IMPACTOR WOULD NOT HOLD THE CUP TIGHT ENOUGH SO WHEN HE STARTED TO IMPACT THE CUP,THE CUP WOULD MOVE ON THE IMPACTOR AND THEREFORE THROW OFF HIS VERSION AND PLACEMENT OF THE CUP. HE THEN TRIED TO MOVE THE CUP WITH THE SECONDARY RIM IMPACTOR TIP(1235-0-014). WHILE TRYING TO MOVE THE CUP THE RIM IMPACTOR TIP BROKE SO WE HAD TO REMOVE THE ADM CUP AND REPOSITION. ON THE SECOND ATTEMPT TO IMPACT THE CUP THE SAME ISSUE HAPPENED WHERE THE IMPACTOR WOULD NOT HOLD THE CUP TIGHT ENOUGH FOR HIM TO IMPACT THE CUP PROPERLY SO WE BAILED ON THE ADM AND IMPLANTED A TRITANIUM PRIMARY SHELL.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY SURGERY, WHEN DR. WAS IMPACTING THE ADM CUP, THE CUP IMPACTOR WOULD NOT HOLD THE CUP TIGHT ENOUGH SO WHEN HE STARTED TO IMPACT THE CUP,THE CUP WOULD MOVE ON THE IMPACTOR AND THEREFOR THROW OFF HIS VERSION AND PLACEMENT OF THE CUP. HE THEN TRIED TO MOVE THE CUP WITH THE SECONDARY RIM IMPACTOR TIP((B)(4)). WHILE TRYING TO MOVE THE CUP THE RIM IMPACTOR TIP BROKE SO WE HAD TO REMOVE THE ADM CUP AND REPOSITION. ON THE SECOND ATTEMPT TO IMPACT THE CUP THE SAME ISSUE HAPPENED WHERE THE IMPACTOR WOULD NOT HOLD THE CUP TIGHT ENOUGH FOR HIM TO IMPACT THE CUP PROPERLY SO WE BAILED ON THE ADM AND IMPLANTED A TITANIUM PRIMARY SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780710 ADM RIM IMPACTOR TIP INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other