BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SIZE BROACH

    MDR report key: 11456705 · Received March 10, 2021

    Report

    Report Number
    0001822565-2021-00675
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    February 17, 2021
    Report Date
    July 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0001822565-2021-01879, 0001822565-2021-01880. D10: UNKNOWN BROACH SIZE 3. UNKNOWN BROACH SIZE 4. UNKNOWN BROACH SIZE 5. UNKNOWN BROACH SIZE 6. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.

    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 PRODUCTS: CATALOG NUMBER: 574101030, LOT NUMBER: 3037909, BRAND NAME: AVENIR CMPL HA STD NC SIZE 3. CATALOG NUMBER: 574101020, LOT NUMBER: 3032773, BRAND NAME: AVENIR CMPL HA STD NC SIZE 2. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2021-00514, 0001822565-2021-00513. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 DURING AN INITIAL HIP ARTHROPLASTY, THAT THE SURGEON BROACHED WITH A SIZE 2 BROACH. HOWEVER, WHEN HE IMPLANTED THE SIZE 2 STEM IMPLANT, IT SANK FURTHER INTO THE BONE CANAL THAN THE BROACH. THE SURGEON BROACHED THEN WITH A SIZE 3 BROACH TO FURTHER PREP THE CANAL. THE SIZE 3 STEM IMPLANT, WAS IMPLANTED INTO THE BONE CANAL AND ALSO SANK FURTHER INTO THE CANAL THAN THE BROACH. THERE WAS NO APPARENT BONE FRACTURES AS CONFIRMED BY RADIOGRAPHS. THE SIZE 3 IMPLANT WAS REMOVED AND THE SURGEON CONTINUED TO FURTHER BROACH UNTIL IT WAS DETERMINED THAT A SIZE 6 BROACH WAS THE LARGEST SIZE THE PATIENT¿S ANATOMY COULD ACCOMMODATE. ANOTHER RADIOGRAPH WAS TAKEN AND THIS TIME THERE WAS CLEARLY A BONE FRACTURE IN THE LATERAL FEMUR AT THE LEVEL OF THE DISTAL END OF THE BROACH. THE SURGEON APPLIED CERCLAGE CABLES AND BYPASSED THE FRACTURE USING AN ACROS MODULAR REVISION STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353688 UNKNOWN SIZE BROACH PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R