BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM REINFORCED CPS-CPS MOD A NAIL

    MDR report key: 6767531 · Received August 4, 2017

    Report

    Report Number
    0001825034-2017-05931
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    January 17, 2019
    Report Date
    May 13, 2025
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; B3; B4; B5; B6; B7; D1; D2; D4; D6A; D6B; D9; D10; E1; G1; G3; G6; H1; H2; H6. D10: 178512 - CPS NUT CO-CR-MO ALLOY - 123500, 178402 - CPS ANCHOR PLUG 12MM - 791910, 178404 - CPS ANCHOR PLUG 14MM - 791920, 178504 - CPS LG H F SPINDLE 12MM PC HA - 619550, 178612 - EXP DSTL FEM 17CM LEFT ASSY - 279450, 178527 - CPS TRANSVERSE PIN 6PK 32MM - 324740, 178530 - CPS TRANSVERSE PIN 6PK 44MM - 933150, 178537 - CPS CENTERING SLEEVE 15MM - 335580, 178538 - CPS CENTERING SLEEVE 16MM - 131480, PM103043 - PLUYM CSTM TIB COMPRESS 400LB - 045130, CP114664 - MAXIM-OSS 3CM SEGMENT - 519990. 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. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. THE EVENT IS CONFIRMED. COSMETIC VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND LIGHT DAMAGES SUCH AS SCRATCHES, GOUGES AND ROUNDED STRAIGHT EDGES. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: METALLOSIS WAS ENCOUNTERED, ''THE COMPONENTS APPEAR TO ROTATE OPPOSITE EACH OTHER'', AND THERE WAS MECHANICAL LOOSENING OF THE ARTHRODESIS NAIL LEFT KNEE, HOWEVER, THE SPINDLES WERE WELL POSITIONED AND WELL-FIXED IN THE BONE. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A LEFT KNEE ARTHRODESIS IS PRESENT AND THE IMPLANT ALIGNMENT IS ANATOMIC. THE FEMORAL AND TIBIAL ARTICULATIONS APPEAR UNREMARKABLE. THERE IS NO EVIDENCE OF IMPLANT DISASSOCIATION ON THESE IMAGES. 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 THAT PATIENT UNDERWENT AN ARTHRODESIS KNEE PROCEDURE UTILIZING PATIENT MATCHED IMPLANTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. DURING THE REVISION, THE ARTHRODESIS NAIL WAS NOTED TO BE LOOSE AND METALLOSIS WAS ENCOUNTERED. THE PATIENT WAS REVISED FROM THE ARTHRODESIS TO A HINGED KNEE IN ORDER TO RESTORE MOBILITY TO THE JOINT. CUSTOM TIBIAL AND FEMORAL COMPONENTS WERE ALSO REVISED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - UNKNOWN COMPRESS TIBIAL COUPLER. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. 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: 0001825034-2017-05932, 0001825034-2017-05933.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN AND INSTABILITY. A REVISION HAS BEEN INDICATED, HOWEVER NO PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546564 CUSTOM REINFORCED CPS-CPS MOD A NAIL PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 466420

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention| H UNKNOWN COMPRESS BEARING.| UNKNOWN COMPRESS TIBIAL TRAY.| UNKNOWN COMPRESS BEARING| UNKNOWN COMPRESS TIBIAL TRAY