BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS SHORT ANCHOR PLUG 12MM

    MDR report key: 11750690 · Received April 29, 2021

    Report

    Report Number
    0001825034-2021-01301
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304461673
    PMA / PMN Number
    K062998
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 161036 - OSS RS NON MOD PLATE SHORT 63 - 728830 178527 - CPS TRANSVERSE PIN 6PK 32MM - 658650 178364 - CPS XS SHT SPDL W PINS 800LBF - 558750 178536 - CPS CENTERING SLEEVE 14MM - 890390 178512 - CPS NUT CO-CR-MO ALLOY - 987810 178710 - CPS TAPER LOCKING CAP / OSS SC - 209010 178711 - CPS/OSS 5CM TPR ADAPT W/OSS SC - 830360 161092 - OSS SEG DSTL FEM 8.5CM RT - 761890 150410 - OSS TIBIAL POLY BEARING 12MM - 050920 150476 - OSS POLY TIBIAL BUSHING - 406170 150477 - OSS POLY FEMORAL BUSHINGS - 928380 150478 - OSS POLY LOCK PIN - 807200 150480 - OSS AXLE - 561280 150493 - OSS REINFORCED YOKE - 561480 150478 - OSS POLY LOCK PIN - 490730 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A SINGLE X-RAY FROM APPROX. 2 MONTHS BEFORE THE REVISION PROCEDURE WAS PROVIDED HOWEVER IT WAS NOT SENT FOR FURTHER REVIEW AS THERE WAS NO OBVIOUS IMPLANT FRACTURE SEEN ON THE IMAGE. NO COMPARISON IMAGES IMMEDIATE POST OP WAS PROVIDED TO DETERMINE IF IMPLANT IS SLIGHTLY OFFSET OR IF IT WAS IMPLANTED THAT WAY, AND NO FULL IMAGE OF IMPLANT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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 THE PATIENT UNDERWENT A REVISION APPROXIMATELY 18 MONTHS POST IMPLANTATION DUE TO A BROKEN ANCHOR PLUG. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 178528 - CPS TRANSVERSE PIN - 097450, 178367 - CPS SM SHT SPDL W PINS - 905950, 178540 - CPS CENTERING SLEEVE - 527300, 178512 - CPS NUT CO-CR-MO ALLOY - 099480, 150410 - OSS TIBIAL POLY BEARING - 002730, 150478 - OSS POLY LOCK PIN - 772830, 150417 - OSS NON-MOD TIB PLATE SHORT 67 - 761070, 178715 - CPS 8.5CM SEG FM OSS TPR LT - 507400, 150476 - OSS POLY TIBIAL BUSHING - 416430, 150493 - OSS REINFORCED YOKE - 666210, 150477 - OSS POLY FEMORAL BUSHINGS - 915230, 150480 - OSS AXLE - 942460. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS NOT RETURNED BY THE PATIENT. 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: 0001825034-2021-01302, 0001825034-2021-01303, 0001825034-2021-01304, 0001825034-2021-01305.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION APPROXIMATELY 18 MONTHS POST IMPLANTATION DUE TO A BROKEN COMPRESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646333 CPS SHORT ANCHOR PLUG 12MM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 917550 00880304461673

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R SEE H10.| SEE H10.