BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR DUAL MOBILITY INSERT

    MDR report key: 9351272 · Received November 20, 2019

    Report

    Report Number
    0002249697-2019-03834
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    October 14, 2019
    Report Date
    February 27, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    UDI-DI
    04546540666017
    PMA / PMN Number
    K103233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4: EXPIRY DATE CORRECTED FROM 31-DEC-2006 TO 30-JUN-2024. H4: MANUFACTURE DATE CORRECTED FROM 03-DEC-2001 TO 20-JUN-2019. ADDITIONAL MFG NARRATIVE REPORTED EVENT: AN EVENT REGARDING A SEATING/LOCKING ISSUE INVOLVING AN MDM LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT REMAINS IMPLANTED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT REJECTED AND STATED THAT - X-RAY PROVIDED DOES NOT CONFIRM EVENT, NEED ADDITIONAL INFORMATION; PRIMARY OPERATIVE REPORT, CLINICAL AND PAST MEDICAL HISTORY AND ADDITIONAL SERIAL DATED X-RAYS. DEVICE HISTORY REVIEW: ALL DEVICES 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. CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING PRIMARY OPERATIVE REPORT, CLINICAL AND PAST MEDICAL HISTORY, ADDITIONAL SERIAL DATED X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    DR (B)(6) COMMENTED THAT ON POST OP X-RAY THE MDM LINER DID NOT LOOK SEATED IN TRIDENT CUP ALTHOUGH AT TIME OF OPERATION IT WAS SOLID & APPEARED TO BE SOLID.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DR FERGUSON COMMENTED THAT ON POST OP X-RAY THE MDM LINER DIDN¿T LOOK SEATED IN TRIDENT CUP ALTHOUGH AT TIME OF OPERATION IT WAS SOLID & APPEARED TO BE SOLID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143649 MODULAR DUAL MOBILITY INSERT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO STRYKER ORTHOPAEDICS-MAHWAH 626-00-42E 72439601 04546540666017

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other