BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-M 1.6MM BEADED CABLE SET VIT

    MDR report key: 4221725 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04129
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    May 13, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDQ
    PMA / PMN Number
    K953818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A DALL MILES CABLE WAS REPORTED. THE CRACK/FRACTURE EVENT AND COMPONENT MALPOSITION WAS CONFIRMED FOLLOWING A REVIEW BY A CLINICAL CONSULTANT. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT INDICATED THAT: FOR TREATMENT OF A FULL FEMORAL FRACTURE, THE USE OF ONLY ONE DM-CABLE IS GROSSLY INADEQUATE, ESPECIALLY WHEN WE ALSO TAKE INTO ACCOUNT THE POSITION OF THE CABLE AT THE FAR DISTAL END OF THE FRACTURE. WITH ONLY ONE DM-CABLE PLACED AT THE FAR END OF THE FRACTURE AND STRONG MUSCLE PULL ABOVE THIS IN PROXIMAL DIRECTION USED FOR TWO UNSTABLE FRACTURE FRAGMENTS, IT IS EASILY CONCEIVABLE THAT ANY RECONSTRUCTION OF THE COMPLEX PROXIMAL FEMORAL FRACTURE IS DOOMED TO FAILURE SUCH AS ALSO OCCURRED IN THIS PATIENT EARLY AFTER IMPLANTATION. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: A REVIEW BY A CLINICAL CONSULTANT CONCLUDED: TYPE AND MAGNITUDE OF INTRAOPERATIVE FEMORAL FRACTURE WERE NOT RECOGNIZED DURING REVISION SURGERY RESULTING IN INADEQUATE RECONSTRUCTION OF THE COMPLEX FRACTURE WITH ONLY ONE DM-CABLE THAT ADDITIONALLY HAD A MALPOSITION. ALL THIS CONTRIBUTED TO AN ACUTE OR CHRONIC OVERLOAD CONDITION ON THE SINGLE DM-CABLE. IF FURTHER INFORMATION AND/OR DEVICE BECOMES AVAILABLE, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT HAD REVISION HIP SURGERY ON (B)(6) 2014 AT (B)(6). DOCTOR USED ONLY 1 DALL MILES CABLE WITH ANOTHER COMPANIES HIP IMPLANTS. THERE WAS NO STRYKER REP AT THIS CASE. THE CABLE APPEARS TO HAVE COME LOOSE.

    Description of Event or Problem · 1

    PATIENT HAD REVISION HIP SURGERY ON (B)(6) 2014 AT (B)(6) CENTER. DOCTOR USED ONLY 1 DALL MILES CABLE WITH ANOTHER COMPANIES HIP IMPLANTS. THERE WAS NO STRYKER REP AT THIS CASE. THE CABLE APPEARS TO HAVE COME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703235 D-M 1.6MM BEADED CABLE SET VIT CERCLAGE, FIXATION JDQ STRYKER ORTHOPAEDICS-MAHWAH 32060602

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention