BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED II GLENOID BASEPLATE 29MM STD POST

    MDR report key: 12011061 · Received June 16, 2021

    Report

    Report Number
    3000931034-2021-00285
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 20, 2021
    Report Date
    February 1, 2022
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386928222
    PMA / PMN Number
    K061439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: PLEASE REFER TO H6 CLINICAL SIGNS CODE. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. BASED ON PREVIOUS SIMILAR CASES, THE ABSENCE OF THE PERIPHERAL GROOVE AROUND THE BASEPLATE, THE REMAINED SOFT TISSUES BETWEEN THE BASEPLATE AND THE GLENOID SPHERE OR INSIDE THE BASEPLATE THREADING HOLE ARE THE MOST PROBABLY CAUSES FOR THIS REPORTED EVENT. MOREOVER, IF THE GLENOID SPHERE IS LEFT IN THE PATIENT WITH THE SAFETY SCREW NOT TIGHTENED, A GREATER RISK OF A SPHERE/BASEPLATE DISASSEMBLY CANNOT BE EXCLUDED IN THE FUTURE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    THE SPHERE DID NOT ENGAGE WITH THE BASEPLATE WHEN THE SPHERE WAS IMPACTED ONTO THE BASEPLATE. BOTH COMPONENTS (THE SPHERE & BASEPLATE) WERE LEFT IN THE PATIENT. SURGEON TRIED SEVERAL TIMES TO ENGAGE THE SPHERE WITH THE BASEPLATE. THE DWD167 SCREWDRIVER WAS USED TO ASSEMBLE THE BASEPLATE AND GLENOSPHERE TOGETHER. THERE WAS A 3-5 MINUTE DELAY. THIS EVENT WAS A PRIMARY SURGERY.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SPHERE DID NOT ENGAGE WITH THE BASEPLATE WHEN THE SPHERE WAS IMPACTED ONTO THE BASEPLATE. BOTH COMPONENTS (THE SPHERE & BASEPLATE) WERE LEFT IN THE PATIENT. SURGEON TRIED SEVERAL TIMES TO ENGAGE THE SPHERE WITH THE BASEPLATE. THE DWD167 SCREWDRIVER WAS USED TO ASSEMBLE THE BASEPLATE AND GLENOSPHERE TOGETHER. THERE WAS A 3-5 MINUTE DELAY. THIS EVENT WAS A PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907830 AEQUALIS REVERSED II GLENOID BASEPLATE 29MM STD POST PROSTHESIS SHOULDER JOINT METAL KWS TORNIER S.A.S. BASEPLATE 29MM STD POST AB7413 03700386928222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other