BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACT OFFSET BROACH HANDLE NDL

    MDR report key: 9218794 · Received October 22, 2019

    Report

    Report Number
    0001825034-2019-04786
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    September 28, 2019
    Report Date
    January 24, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS CONFIRMED WITH PRODUCT RECEIVED. VISUAL INSPECTION CONFIRMED THAT THE PIN CAP AT THE DISTAL END OF THE HANDLE HAS FRACTURED FROM THE DEVICE. THE FRACTURED PORTION WAS RETURNED. IMPACT MARKS WERE OBSERVED ON THE HANDLE NEAR THE STRIKE PLATE AND THE STRIKE PLATE ITSELF. OXIDATION AND SCRATCHING WAS FOUND ON THE DISTAL END OF THE HANDLE. 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 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 PRODUCTS: CATALOG#: 010000847, G7 NEUTRAL E1 LINER 32MM C, LOT#: 6483906; CATALOG#: 110017121, G7 FINNED BM 3 HOLE SHELL 48C, LOT#: 6361125; CATALOG#: 51-102050, TPRLC XR FP TYPE1 PPS 5X130MM, LOT#: 6222362; CATALOG#: 650-1056, CER BIOLOXD OPTION HD 32MM, LOT#: 2019011392; CATALOG#: 650-1066, CER OPT TYPE 1 TPR SLEVE 0MM, LOT#: 2019030131. FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE RASPING WITH THE EXACT BROACH HANDLE, THE PIN CAP FELL OFF THE HANDLE AND INTO THE PATIENT'S WOUND. THE OBJECT WAS DISCOVERED POST-OP AND WAS REMOVED. 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
    1013915 EXACT OFFSET BROACH HANDLE NDL PROSTHESIS, HIP LXH ZIMMER BIOMET, INC. N/A 654020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R