BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ML/HD RNGLC FINN ACET HAP 52MM

    MDR report key: 5554177 · Received April 7, 2016

    Report

    Report Number
    3002806535-2016-00179
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    March 15, 2016
    Report Date
    August 8, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, THE ACETABULAR CUP AND LOCKING RING SHOWED EVIDENCE OF INDENTATIONS AND DEBRIS. THE LOCKING RING WAS ALSO BENT. HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS AND PRECAUTIONS, NUMBER 3 STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." NUMBER 8 STATES, "THE SURGEON IS TO BE THOROUGHLY FAMILIAR WITH THE IMPLANTS, INSTRUMENTS AND SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY." NUMBER 20 STATES, "PRIOR TO SEATING THE LINER INTO THE SHELL COMPONENT, ALL SURGICAL DEBRIS (TISSUE FRAGMENTS, ETC.) MUST BE REMOVED FROM THE INTERIOR OF THE SHELL COMPONENT, AS DEBRIS MAY INHIBIT THE LOCKING MECHANISM FROM ENGAGING AND SECURING THE LINER INTO THE SHELL COMPONENT."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED 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 K030055.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2016. DURING THE PROCEDURE, THE SURGEON IMPACTED THE ACETABULAR CUP. AFTER IMPACTION, THE SURGEON NOTICED THE LOCKING RING WAS OUT OF POSITION. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO CORRECT THE LOCKING RING POSITION. THE ACETABULAR CUP WAS REMOVED, THE ACETABULUM WAS REAMED AGAIN AND A LARGER SIZE ACETABULAR CUP WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209394 ML/HD RNGLC FINN ACET HAP 52MM PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3628400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention