BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R/B RLOC LHOLE SHL 58MM SZ 25

    MDR report key: 10749873 · Received October 28, 2020

    Report

    Report Number
    0001825034-2020-03909
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 7, 2020
    Report Date
    January 20, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K050124
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE CUP WAS DETERMINED TO BE NOT REPORTABLE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE CUP WAS DETERMINED TO BE NOT REPORTABLE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER 12-115123 ITEM NAME CER BIOLOXD MOD HD 36MM +6 NK LOT # 414000. ITEM NUMBER 192115 ITEM NAME ECHO POR FMRL LAT NC 15X155MM LOT # 565070. ITEM NUMBER 103535 ITEM NAME TI LOW PROFILE SCREW 6.5X40MM LOT # 502030. ITEM NUMBER 31-323230 3.2MMX30MM RNGLC+ ACET DRL BIT 492750. ITEM NUMBER XL-105915 ITEM NAME ARCOMXL 36MM RLC LNR HW SZ25 LOT # 851840. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03900.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL RIGHT HIP ARTHROPLASTY, WHEN CHECKING FOR STABILITY THE LINER POPPED OUT OF THE CUP. SURGEON TRIED IMPACTING THE LINER IN AGAIN WITH NO SUCCESS. ALSO CHECKED THE LOCKING RING AND IT WAS FINE. THE SURGEON REMOVED MORE BONE AROUND THE RIM OF THE CUP THINKING THAT'S WHAT WAS INTERFERING WITH THE LINER FULLY SEATING. HE WAS NEVER ABLE TO GET THE LINER TO SEAT INTO THE CUP AND FINALLY USED A DIFFERENT LINER. UPON IMPACTING THE NEW LINER IT WENT IN WITHOUT ISSUE ON THE FIRST TRY. IT WAS NOTED THIS CAUSED A ONE HOUR 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
    1216943 R/B RLOC LHOLE SHL 58MM SZ 25 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 302910

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR