BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4092445 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03490
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING AN UNKNOWN SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT CONFIRMED THE EVENT BUT COULD NOT DETERMINE A ROOT CAUSE. "I HAVE LOOKED AT THE NEW INFORMATION CONCERNING THIS SECOND REVISION FOR RECURRENT DISLOCATION SOME 4-MONTHS AFTER THE PREVIOUS FOR A METAL ION PROBLEM. RECURRENT DISLOCATION HAS EITHER PATIENT-RELATED OR PROCEDURE-RELATED ROOT CAUSES OR MORE OFTEN A COMBINATION OF BOTH. THIS IS EVIDENT FROM THE CLASSIFICATION FOR SUCH ACCORDING TO DORR THAT ONLY RECOGNIZES SUCH ROOT CAUSES WHILE DEVICE RELATED PROBLEMS ARE NOTORIOUSLY ABSENT. DORR CLASSIFICATION OF UNSTABLE TOTAL HIP ARTHROPLASTY. TYPE 1 POSITIONAL INSTABILITY (HIP MOVES BEYOND PHYSIOLOGICAL RANGE OF MOTION). TYPE 2 SOFT TISSUE IMBALANCE. TYPE 3 MALPOSITION OF HIP JOINT COMPONENTS. DIAGNOSIS OF RECURRENT DISLOCATIONS LEANS HEAVILY ON X-RAY INFORMATION BECAUSE COMPONENT MALPOSITION IS AN IMPORTANT CRITERION FOR CLASSIFICATION. IN THIS CASE A TYPE 2 PROBLEM MIGHT PLAY AN ADDITIONAL ROLE GIVEN THE USUAL SOFT TISSUE LAXITY THAT IS PRESENT THE FIRST FEW MONTHS AFTER ANY ARTHROPLASTY, THE MORE SO AFTER REVISION SURGERY. BECAUSE THERE ARE NO X-RAYS AVAILABLE FOR REVIEW, THIS CASE NOT BE SOLVED DUE TO LACK OF INFORMATION ALTHOUGH AS MENTIONED ABOVE, AN ADVERSE MIX OF PATIENT-RELATED AND PROCEDURE-RELATED WOULD ACT AS THE MOST SUSPECTED ROOT CAUSE OF FAILURE WITH DEVICE-RELATED PROBLEMS NOT HAVING ANY PLACE IN THE FAILURE SCENARIO. THERE IS UNFORTUNATELY HOWEVER NO SUBSTANTIAL PROOF FOR THIS ASSUMPTION DUE TO LACK OF ADEQUATE INFORMATION." CONCLUSIONS: THE ROOT CAUSE OF THIS INVESTIGATION COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, X-RAYS, OPERATIVE REPORTS, PATIENT HISTORY ARE NEEDED TO FULLY INVESTIGATE THIS EVENT.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN CUP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE EVAL: HOSPITAL POLICY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A LEFT HIP DUE TO DISLOCATION. THE CUP, LINER AND BALL WERE REMOVED. HOSPITAL RETAINED IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A LEFT HIP DUE TO DISLOCATION. THE CUP, LINER AND BALL WERE REMOVED. HOSPITAL RETAINED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573335 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention