BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR 28X49MM

    MDR report key: 6808424 · Received August 21, 2017

    Report

    Report Number
    0001825034-2017-06499
    Event Type
    Injury
    Date Received
    August 21, 2017
    Report Date
    August 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK833175
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S):- PART: 163662, NAME: 28MM MOD HD STD NECK TP1 TAPER, LOT: 494570. PART: 12-150310, NAME: ECHO PF 10MM STD FEMORAL, LOT: 012950. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. THE REVIEW OF THE DEVICE HISTORY REPORT FOUND NO DEVIATIONS OR ANOMALIES. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE INVESTIGATION RESULTS CONCLUDED THAT A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS:0001825034-2016-04349, 0001825034-2017-06500.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS EXPERIENCED PAIN FOLLOWING A HIP PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588693 RINGLOC BI-POLAR 28X49MM PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 111540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention