BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3926470 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02622
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN SCREWS. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING METALLOSIS INVOLVING A UNKNOWN SCREWS WAS REPORTED. THE EVENT WAS NOT CONFIRMED. REVIEW OF THE PROVIDED PATIENT DETAILS AND REPORTED EVENT BY A CLINICAL CONSULTANT CONCLUDED: ISSUE WITH A TRITANIUM CUP REVISION WITH ASSOCIATED MDM LINER AN UNKNOWN TIME AFTER PRIMARY ARTHROPLASTY IN A FEMALE PATIENT OF (B)(6) WITH OBESITY. SURGEON REPORTED THERE WAS SIGNIFICANT METALLOSIS BETWEEN MDM LINER AND TRITANIUM SHELL. ALSO SIGNIFICANT METALLOSIS BETWEEN SHELL AND BONE. NO X-RAYS ARE AVAILABLE FOR REVIEW WHILE ALSO NO IMPLANTS WERE RETURNED FOR ANALYSIS. THE LOCATION OF THE REPORTED METALLOSIS BEHIND MDM SHELL AND BETWEEN CUP SHELL AND BONE POINTS TO A SOURCE OF METAL DEBRIS GENERATION ON THE BACK SIDE OF THE CUP WHILE THE USE OF AUGMENT AND SCREWS MOST PROBABLY POINTS TO A FAILED STABILIZATION OF THESE DEVICES AT INDEX SURGERY WHEN BONE GRAFTS WERE PRESENT AND A METAL AUGMENT (TITANIUM OR TANTALUM) WAS USED FOR ADDITIONAL STABILIZATION. IT APPEARS VERY PROBABLE THAT FAILURE OF THE CUP, AUGMENT SCREW COMBINATION FAILED TO ACQUIRE STABLE BONY FIXATION AND THUS BECAME SUBJECT TO A LOOSENING PROCESS THAT WAS ACCOMPANIED BY DESTABILIZATION OF AUGMENT AND SCREWS AND THUS WAS SUBJECT TO ABRASIVE WEAR BETWEEN THE INVOLVED METAL SURFACES. THIS CAUSED PAIN WHICH ESTABLISHED THE INDICATION FOR REVISION SURGERY AS MOST PROBABLY CUP LOOSENING ALTHOUGH THERE IS NO EXPLICIT CONFIRMATION FIR SUCH DUE TO LACK OF INFORMATION. IT STILL APPEARS THE MOST PROBABLE FAILURE SCENARIO WITH THE MOST PLAUSIBLE AND COMPATIBLE EXPLANATION OF ALL REPORTED FACTS AND FINDINGS. AS SUCH, A PROCEDURE-RELATED FAILURE MECHANISM HAS THE HIGHEST PROBABILITY AS FAILURE MODE ALTHOUGH THIS HIGH SUSPICION CANNOT BE DOCUMENTED WITH ADEQUATE EVIDENCE THROUGH X-RAY VERIFICATION OF COMPONENTS OR EXPLANT MATERIALS ANALYSIS. THE PROBABILITY OF DEVICE-RELATED MECHANISMS APPEARS VERY LOW TO ABSENT WHILE PATIENT OBESITY MAY HAVE PLAYED A SECONDARY BUT CERTAINLY NOT A PRINCIPAL ROLE IN THE FAILURE SCENARIO. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO MEDICAL RECORDS AND/OR DEVICE WERE RECEIVED. CLINICAL CONSULTANT INDICATED IT APPEARS VERY PROBABLE THAT FAILURE OF THE CUP, AUGMENT SCREW COMBINATION FAILED TO ACQUIRE STABLE BONY FIXATION AND THUS BECAME SUBJECT TO A LOOSENING PROCESS THAT WAS ACCOMPANIED BY DESTABILIZATION OF AUGMENT AND SCREWS AND THUS WAS SUBJECT TO ABRASIVE WEAR BETWEEN THE INVOLVED METAL SURFACES. 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

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT ACETABULAR. DOCTOR STATED THERE WAS SIGNIFICANT METALLOSIS BETWEEN MDM LINER AND TRITANIUM SHELL. ALSO SIGNIFICANT METALLOSIS BETWEEN SHELL AND BONE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT ACETABULAR. DOCTOR STATED THERE WAS SIGNIFICANT METALLOSIS BETWEEN MDM LINER AND TRITANIUM SHELL. ALSO SIGNIFICANT METALLOSIS BETWEEN SHELL AND BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405127 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention