BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET COMPRESS SPINDLE 38MM

    MDR report key: 6832396 · Received August 30, 2017

    Report

    Report Number
    0001825034-2017-06819
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    June 30, 2017
    Report Date
    March 22, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BIOMET COMPRESS, CATALOG # CP116194, LOT # CP116194, BIOMET COMPRESS CENTERING SLEEVE 17MM, CATALOG # 178539, LOT # 234260, BIOMET COMPRESS SHORT ANCHOR PLUG, CATALOG # 178556, LOT # 957150, BIOMET COMPRESS TRANSVERSE PIN, CATALOG # 178528, LOT # 770590, TRANSDERMAL COMPRESS ADAPTER, CATALOG # CP116193, LOT # 277350, BIOMET COMPRESS NUT, CATALOG # 178512, LOT # 178512. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE - (B)(6) 2016. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE DETERMINED TO BE HUMAN FACTORS. THE PATIENT'S SON STATED THAT HIS FATHER STOOD ON THE PROSTHESIS TOO SOON AFTER SURGERY. 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY NINE MONTHS POST-IMPLANTATION DUE TO BONE FRACTURE AND LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609758 BIOMET COMPRESS SPINDLE 38MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 288370

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R