BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R/B RLOC LHOLE SHL 52MM SZ 23

    MDR report key: 11666163 · Received April 14, 2021

    Report

    Report Number
    0001825034-2021-01084
    Event Type
    Injury
    Date Received
    April 14, 2021
    Report Date
    July 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K050124
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: CAT# 105903 RNGLC LNR 28MM HI-WALL 23 LOT# 005820. CAT# 163662 28MM MOD HD STD NECK TP1 TAPER LOT# 032620. CAT# X181311 BI-METRIC/X POR COLLAR 11X135 LOT# 941910. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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 - 2021 - 01083. 0001825034 - 2021 - 01085. 0001825034 - 2021 - 01086.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY THE PATIENT HAS BEEN INDICATED FOR A REVISION, HOWEVER, A REVISION HAS NOT BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561470 R/B RLOC LHOLE SHL 52MM SZ 23 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 413480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10 NARRATIVE.