BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM RINGLOC LINER HIWALL

    MDR report key: 9690175 · Received February 10, 2020

    Report

    Report Number
    0001825034-2020-00593
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    January 23, 2020
    Report Date
    May 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K023357
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS ABLE TO BE CONFIRMED BY X-RAYS. RADIOGRAPHS IDENTIFIED LEFT TOTAL HIP ARTHROPLASTY WITH POLYETHYLENE WEAR OF THE ACETABULAR CUP. THE LINER WEAR WAS CONFIRMED. HOWEVER, THE IMPINGEMENT WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM# 163660/COCR MOD HD / LOT # 221520, ITEM # 12-104152/ SHELL /LOT # 235210, ITEM # 103808/ TRPLC PR FMRL /LOT # 761580, ITEM # 631034/ REDI-FLOW REG SYS /LOT # 200901, ITEM # 103530/ TI LOW PROFILE SCREW /LOT # 778480, ITEM # 103534/ TI LOW PROFILE SCREW /LOT # 304674. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2020 -00594, 0001825034 -2020 -00635.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION PROCEDURE 19 YEARS POST-IMPLANTATION DUE TO PAIN. DURING THE REVISION PROCEDURE, THE SURGEON INDICATED THAT THE TRUNNION OF THE STEM WAS IMPINGING AGAINST THE HI-WALL LIP OF THE POLYETHYLENE LINER WHEN PATIENT WAS IN ABDUCTION. FURTHER, THE LINER WAS FOUND TO BE WORN. THE LINER AND HEAD WERE REMOVED AND REPLACED. 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
    148677 ARCOM RINGLOC LINER HIWALL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 579380

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R