BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR ACETABULAR CUP

    MDR report key: 6716655 · Received July 17, 2017

    Report

    Report Number
    0001825034-2017-04967
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    March 16, 2017
    Report Date
    August 3, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK833175
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. EVENT DATE - A FEW WEEKS POST-IMPLANTATION; DURING (B)(6) 2016. EXPLANT DATE - A FEW WEEKS POST-IMPLANTATION; DURING (B)(6) 2016. CONCOMITANT MEDICAL PRODUCTS: TAPERLOC FEMORAL STEM 103207 LOT 062920 OR ECHO FEMORAL STEM 12-151309 LOT 591440 (UNABLE TO DETERMINE WHICH STEM IMPLANTED). THIS INFORMATION DID NOT ALTER PREVIOUS INVESTIGATION CONCLUSIONS. 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). INFORMATION WAS PREVIOUSLY SUBMITTED ON (B)(4). CONCOMITANT MEDICAL PRODUCTS - 28 MM DIA COCR MOD HD -3 MM NK/ PN 163661/ LN 253640. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. PATIENT HAD A HISTORY OF FALLS. HOWEVER, IT IS UNSURE IF A FALL CAUSED THIS DISLOCATION. 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: 0001825034-2017-04968.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW WEEKS AFTER A TOTAL HIP ARTHROPLASTY, PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION. THE CLOSED REDUCTION WAS INSUFFICIENT AND THE SURGEON OPTED TO REVISE THE PATIENT'S ACETABULAR CUP. THE PATIENT REPORTEDLY HAD A HISTORY OF FREQUENT FALLS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION APPROXIMATELY FOUR MONTHS POST IMPLANTATION AFTER A FAILED CLOSED REDUCTION. PATIENT HAD A HISTORY OF FREQUENT FALLS. THERE WERE NO COMPLICATIONS OR DELAYS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497852 RINGLOC BI-POLAR ACETABULAR CUP PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 444790

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Hospitalization| R