BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X E1 H/W 58/36MM 25

    MDR report key: 8365658 · Received February 25, 2019

    Report

    Report Number
    0001825034-2019-00762
    Event Type
    Injury
    Date Received
    February 25, 2019
    Date of Event
    March 21, 2013
    Report Date
    July 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND MEDICAL RECORDS. X-RAYS REVEALED THE FEMORAL HEAD DOES NOT APPEAR TO BE SEATED WITHIN THE ACETABULAR CUP WITH SUGGESTION OF MILD ANTERIOR SUBLUXATION. ASYMMETRIC POSITION OF THE FEMORAL HEAD WITHIN THE ACETABULAR CUP SUGGESTING POLYETHYLENE WEAR. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 · 0

    CONCOMITANT MEDICAL PRODUCTS- PART: 131358BM RINGLOC-X LOT: 2466069 PART: 162035BM BIMETRIC STEM LOT: 1563154 PART: 11-363663 MODULAR HEAD LOT: 992000.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT HIP ARTHROPLASTY AND SUBSEQUENTLY, THE PATIENT WAS REVISED THREE DAYS LATER DUE TO LAXITY AND DURING SURGERY A HEMATOMA WAS NOTED AND REMOVED. THE HEAD AND LINER WERE REMOVED AND REPLACED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT HIP ARTHROPLASTY AND SUBSEQUENTLY, THE PATIENT WAS REVISED THREE DAYS LATER DUE TO LAXITY. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: HEAD: 0001825034-2019-00766.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY AND SUBSEQUENTLY, THE PATIENT WAS REVISED 3 DAYS LATER DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159258 RINGLOC-X E1 H/W 58/36MM 25 HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 2832691

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R