BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP E1 28X41MM

    MDR report key: 6094448 · Received November 10, 2016

    Report

    Report Number
    0001825034-2016-04659
    Event Type
    Injury
    Date Received
    November 10, 2016
    Report Date
    September 5, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    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 · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051569.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: PATIENT SEX UPDATED TO FEMALE

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. LOCK RING AND SHELL WERE RETURNED AND EVALUATED AGAINST THE COMPLAINT. UPON RETURN, LOCKING RING IS FOUND TO BE DISASSEMBLED FROM THE SHELL AND ALSO FOUND TO BE BENT. WIDTH AND THICKNESS OF THE LOCKING RING FOUND NO DEVIATIONS FROM THE PRINT AND ALSO WIDTH OF THE SHELL GROOVE FOUND TO BE CONFORMING, WHICH INDICATES THE DEVICES WERE MANUFACTURED TO THE SPECIFICATIONS. DEFORMATION TO LOCK RING LIKELY OCCURRED DURING LINER INSERTION. LINER WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 DURING A TOTAL HIP ARTHROPLASTY, THE SURGEON HAD DIFFICULTY ASSEMBLING THE ACETABULAR LINER AND SHELL. IT WAS NOTED THAT THE RING WAS DEFORMED, IT IS UNKNOWN AT WHICH POINT THE RING WAS DEFORMED. A DIFFERENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE, RESULTING IN A FORTY-FIVE MINUTE DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745667 RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP E1 28X41MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 708040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R