BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS SHORT ANCHOR PLUG 10MM

    MDR report key: 19960275 · Received August 12, 2024

    Report

    Report Number
    0001825034-2024-01989
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    July 12, 2024
    Report Date
    January 10, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304461659
    PMA / PMN Number
    K062998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 MEDICAL DEVICES: OSS 3CM TAPERED DIAPH SEGMENT CATALOG#: 151836, LOT#: 514260, OSS POLY TIBIAL BUSHING CATALOG#: 150476, LOT#: 248780, OSS REINFORCED YOKE CATALOG#: 150493, LOT#: 65676297, OSS POLY LOCK PIN CATALOG#: 150478, LOT#: 65676149, OSS 9CM PROX TIB MOD COCR CATALOG#: CP113462, LOT#: 104710, OSS POLY FEMORAL BUSHINGS CATALOG#: 150477, LOT#: 65821078, CPS NUT CO-CR-MO ALLOY CATALOG#: 178512, LOT#: 65753470, OSS AXLE CATALOG#: 150480, LOT#: 65803980, OSS 3CM RESURFACING LT CATALOG#: 151806, LOT#: 532530, OSS CEMENTED IM STEM 13MMX90MM CATALOG#: 150362, LOT#: 777660, CPS XS SHT SPDL W PINS 800LBF CATALOG#: 178364, LOT#: 636630, CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG#: 178711, LOT#: 65804239, CPS TRANSVERSE PIN 6PK 28MM CATALOG#: 178526, LOT#: 173300, CPS TRANSVERSE PIN 6PK 24MM CATALOG#: 178525, LOT#: 501720, OSS TIBIAL POLY BEARING 18MM CATALOG#: 150413, LOT#: 622640. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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/CORRECTED. UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED DAMAGE IN THE FORM OF NICKS AND GOUGES. THE SHAFT OF THE IMPLANT IS FRACTURED WITH THE END OF THE POST NOT RETURNED. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. THE IMPLANT WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED FATIGUE STRIATION ON THE FRACTURED SURFACE SUGGEST A FATIGUE FAILURE MODE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL AND IT WAS DETERMINED FURTHER REVIEW WOULD NOT ENHANCE THE INVESTIGATION. COMPLAINT IS CONFIRMED WITH PRODUCT RETURN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY SIXTEEN (16) MONTHS POST-IMPLANTATION DUE TO FRACTURE OF THE ANCHOR PLUG. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725074 COMPRESS SHORT ANCHOR PLUG 10MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 860830 00880304461659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11