BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC HIP SYSTEM 2 HOLE ACETABULAR SHELL UNIVERSAL WITH APICAL DOME HOLE

    MDR report key: 6691637 · Received July 6, 2017

    Report

    Report Number
    0001825034-2017-04570
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    May 10, 2017
    Report Date
    June 21, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK092130
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PATIENT'S BIRTHDATE WAS SOMETIME IN (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE CUP SHOWS SIGNS OF DEBRIS IN THE POROUS COATING FROM THE ATTEMPTED IMPLANTATION. THE LOCKING RING TO THE CUP IS TWISTED AND MISSHAPEN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CONCOMITANT PRODUCTS: XL-053250 3901634 RLOC-X ARCOMXL H/W 50/32MM UK. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04571.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE LINER COULD NOT BE IMPLANTED INTO THE SHELL SUCCESSFULLY. THE SURGEON REMOVED AND REPLACED THE LINER AND SHELL CAUSING A 40 MINUTE SURGERY DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471507 RINGLOC HIP SYSTEM 2 HOLE ACETABULAR SHELL UNIVERSAL WITH APICAL DOME HOLE PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 499890

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other