BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS SHORT ANCHOR PLUG 12MM

    MDR report key: 14829524 · Received June 27, 2022

    Report

    Report Number
    0001825034-2022-01464
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    June 2, 2022
    Report Date
    October 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304461703
    PMA / PMN Number
    K062998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: CPS XS SHT SPDL W PINS: CATALOG#178363, LOT#418040; CPS/OSS 5CM TPR ADAPT W/OSS SC: CATALOG#178711, LOT#942410; CPS CENTERING SLEEVE 14MM: CATALOG#178536, LOT#694120; OSS RS 14MM LS TIBIAL BEARING: CATALOG#161095, LOT#796120; OSS RS AXLE: CATALOG#161035, LOT#689930; OSS RS POLY FEM BUSHINGS SET/2: CATALOG#161034, LOT#353990; OSS RS 9CM MOD PROX TIB BODY: CATALOG#161027, LOT#376450; OSS RS 5CM RESURFACING RT: CATALOG#151803, LOT#555740; OSS CMNTD PROX TIB STEM 11X150: CATALOG#150445, LOT#125540; OSS POLY BUMPER LOCK PIN: CATALOG#150510, LOT#704100; OSS REINFORCED YOKE: CATALOG#150493, LOT#046330; OSS POLY LOCK PIN: CATALOG#150478, LOT#887350; OSS POLY TIBIAL BUSHING: CATALOG#150476, LOT#173270; BIOMET BONE CEMENT R 1X40: CATALOG#110035372, LOT#Y04BAI2201. REPORT SOURCE: FOREIGN: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT FELL, WHICH RESULTED IN PAIN AND AN INABILITY TO STAND UP. EXAMINATION REVEALED THAT THE ROOT PART OF THE ANCHOR PLUG IMPLANT HAD FRACTURED. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017920 CPS SHORT ANCHOR PLUG 12MM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. 178554 037940 00880304461703

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE.