BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOBLOCK INSERTER HANDLE

    MDR report key: 11646953 · Received April 11, 2021

    Report

    Report Number
    0001825034-2021-00931
    Event Type
    Injury
    Date Received
    April 11, 2021
    Date of Event
    March 24, 2021
    Report Date
    August 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWA
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED A CYLINDRICAL STRUCTURE WHICH IS ISODENSE TO THE SURROUNDING BONE PROJECTING ALONG THE LATERAL ASPECT OF THE ACETABULAR CUP. THIS IS NONSPECIFIC AND THE ETIOLOGY IS UNKNOWN, BUT COULD REPRESENT THE SHEARED OFF INSERTER DESCRIBED ON THE EVENT/DEFICIENCY DESCRIPTION. THE HARDWARE IS OTHERWISE INTACT. THERE IS A FRACTURE SEEN IN THE PROXIMAL DIAPHYSIS OF THE FEMUR, PRESUMABLY PRESENT PRIOR TO THE SURGICAL PROCEDURE. CERCLAGE WIRES ALSO SEEN IN THE PROXIMAL FEMORAL DIAPHYSIS. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED THE DEVICE HAS SCUFFING ON THE SHAFT OF THE DEVICE ALONG WITH IMPACT MARKS ON THE STRIKE PLATE. THE TIP OF THE DEVICE HAD FRACTURED AND WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 00223200418 64952406 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH; 00223200418 64914742 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH; 163662 707860 28MM MOD HD STD NECK TP1 TAPER; 11-304114 821440 ARCOS 14X210MM BRCH BODY HI; 11-165222 541770 RINGLOC BI-POLAR 28X49MM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE LOCATION OF THE DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEFT TOTAL HIP ARTHROPLASTY, UPON IMPACTING THE STEM IMPLANT, THE INSERTER FRACTURED OFF AT THE END OF THE THREADS. THE SURGEON ELECTED TO LEAVE THE FRACTURED PIECE IN THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544044 MONOBLOCK INSERTER HANDLE IMPACTOR HWA ZIMMER BIOMET, INC. N/A 226970

    Patients

    Seq Age Sex Outcome Treatment
    1 Other