BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS

    MDR report key: 6832713 · Received August 30, 2017

    Report

    Report Number
    0002249697-2017-02649
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    August 6, 2017
    Report Date
    January 10, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    UDI-DI
    04546540665898
    PMA / PMN Number
    K103233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: RETURNED TO MANUFACTURER ON; DEVICE EVALUATED BY MFG. AN EVENT REGARDING DISLOCATION INVOLVING AN ADM LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: THE RETURNED PART WAS VISUALLY INSPECTED BY SUPPORT STAFF AND EXTENSIVE DAMAGE WAS OBSERVED ON BOTH THE INNER RIM AND OUTER SPHERES, POTENTIALLY CAUSED DURING THE HEAD DISASSOCIATION.. DIMENSIONAL INSPECTION: "THE RETURNED DEVICE WAS RE-INSPECTED AS PER IGS-0032504 VER. 2, AND FOUND TO BE FAILING FOR "A SPHERE DIAMETER", "INNER SPHERE DIAMETER E" AND "B DIAMETER" ABOVE THEIR RESPECTIVE UPPER TOLERANCES. A REVIEW OF THE ORIGINAL DHR CONFIRMED THAT THE A-SPHERE DIAMETER, INNER SPHERE DIAMETER E AND THE B DIAMETER OF THE RETURNED DEVICE WERE IN SPECIFICATION AT THE TIME OF MANUFACTURE. (THE "A", "B" AND "E" DIMENSIONS ARE CHECKED ON I 00% OF PARTS DURING THE IN-PROCESS INSPECTION). IT IS LIKELY THAT THE ASSEMBLY AND DISASSOCIATION OF THE LINER AND FEMORAL HEAD RESULTED IN THE "A", "B" AND "E" DIAMETERS GOING OUT OF SPECIFICATION." -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT CONCLUDED. "PRINCIPAL ROOT CAUSE OF FAILURE THUS WAS CUP MALPOSITION IN A FAR MEDIALIZED POSITION WITHIN THE ACETABULUM LEADING TO BONY IMPINGEMENT AND RECURRENT DISLOCATION. BECAUSE CUP POSITION WAS THE PRINCIPAL PROBLEM AND THE SURGEON IS RESPONSIBLE FOR OPTIMAL COMPONENT PLACEMENT, PRINCIPAL ROOT CAUSE OF FAILURE IS PROCEDURE-RELATED. - NO EVIDENT PATIENT-RELATED FACTORS, BODY WEIGHT AS WELL AS ACTIVITY LEVEL WERE NORMAL. NO INDICATIONS FOR PRESENCE OF DEVICE-RELATED FACTORS WERE SEEN, CONSISTENT WITH THE TYPE OF FAILURE. AS SUCH IS THIS PI CASE NOT DEVICE-RELATED." "PROCEDURE-RELATED FACTORS: - CUP MALPOSITION IN FAR MEDIALIZED POSITION WITHIN THE ACETABULAR BONE. - POTENTIAL INTRAPROSTHETIC DISLOCATION OF MDM IS A DESIGN-RELATED CHARACTERISTIC OF THE DEVICE. PATIENT-RELATED FACTORS - NONE EVIDENT. DEVICE-RELATED FACTORS: - NONE. DIAGNOSIS: - CUP MALPOSITION IN FAR MEDIALIZED POSITION WITHIN THE ACETABULAR BONE HAS CONTRIBUTED TO BONY IMPINGEMENT CAUSING RECURRENT DISLOCATION WITH ULTIMATELY AN INTRAPROSTHETIC DISLOCATION OF THE MDM CONSTRUCT DURING ATTEMPT AT CLOSED REDUCTION AND THUS REQUIRING REVISION SURGERY." -DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE RESULTS OF THE INVESTIGATION INDICATE THAT "AS SUCH IS THIS PI CASE NOT DEVICE-RELATED" {...} "CUP MALPOSITION IN FAR MEDIALIZED POSITION WITHIN THE ACETABULAR BONE HAS CONTRIBUTED TO BONY IMPINGEMENT CAUSING RECURRENT DISLOCATION WITH ULTIMATELY AN INTRAPROSTHETIC DISLOCATION OF THE MDM CONSTRUCT DURING ATTEMPT AT CLOSED REDUCTION AND THUS REQUIRING REVISION SURGERY". NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT REVISION SURGERY, DUE TO RECURRING RIGHT HIP DISLOCATION FOLLOWING A EXETER MDM (B)(6) 2016. PATIENT HAD 4 PREVIOUS HIP DISLOCATIONS THAT HAVE BEEN REDUCED. ON LAST HIP RELOCATION ATTEMPT THE FEMORAL HEAD BECAME DISENGAGED FROM THE MDM INSERT. PATIENT TAKEN INTO THEATRE FOR OPEN HIP REDUCTION EXPLANT OF STEM AND ACETABULAR LINER/INSERT, AND INSERTION OF A CAPTIVE LINER AND CEMENT IN CEMENT STEM.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION SURGERY, DUE TO RECURRING RIGHT HIP DISLOCATION FOLLOWING A EXETER MDM (B)(6) 2016. PATIENT HAD 4 PREVIOUS HIP DISLOCATIONS THAT HAVE BEEN REDUCED. ON LAST HIP RELOCATION ATTEMPT THE FEMORAL HEAD BECAME DISENGAGED FROM THE MDM INSERT. PATIENT TAKEN INTO THEATRE FOR OPEN HIP REDUCTION EXPLANT OF STEM AND ACETABULAR LINER/INSERT, AND INSERTION OF A CAPTIVE LINER AND CEMENT IN CEMENT STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612382 RESTORATION ADM X3 INS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU LZO STRYKER ORTHOPAEDICS-MAHWAH 291212 04546540665898

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R