BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS SHORT ANCHOR PLUG 12MM

    MDR report key: 11562603 · Received March 24, 2021

    Report

    Report Number
    0001825034-2021-00861
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    March 5, 2021
    Report Date
    June 4, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304461703
    PMA / PMN Number
    K062998
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H3; H6 VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED A FRACTURE OF THE ANCHOR PLUG FROM THE SPINDLE. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FRACTURE OF THE RIGHT KNEE DISTAL FEMORAL REPLACEMENT IMPLANT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT, FRACTURE IS A KNOWN ADVERSE EFFECT OF THE SYSTEM. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 150465 - OSS 5CM DIAPHYSEAL SEGMENT - 384970; 150354 - OSS 7CM SEGMENTAL FEMORAL RT - 587020; 150493 - OSS REINFORCED YOKE - 602080; 150480 - OSS AXLE - 516460; 150477 - OSS POLY FEMORAL BUSHINGS - 790160; 150476 - OSS POLY TIBIAL BUSHING - 967230; 150410 - OSS TIBIAL POLY BEARING 12MM - 050900; 150478 - OSS POLY LOCK PIN - 090530. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OSS COMPRESS APPROXIMATELY 6 MONTHS AGO. THE SURGICAL TEAM WAS INFORMED THE PATIENT HAD STOPPED HIS CHEMOTHERAPY, HOWEVER, AT THE PATIENT'S 2 MONTH POST-OP APPOINTMENT, IT WAS NOTICED THAT ROD FROM THE ANCHOR PLUG THAT CONNECTS TO THE SPINDLE HAD BENT AND THERE WAS NO NEW BONE GROWTH. THE PATIENT HAD CONTINUED HIS CHEMOTHERAPY AND THE BAR FRACTURED AND SUBSEQUENTLY UNDERWENT A REVISION 2 MONTHS LATER. THE SURGEON CUT JUST ABOVE THE ANCHOR PLUG IN ORDER TO PRESERVE THE PINS AND BUSHINGS AND ALSO REPLACED THE FEMORAL COMPONENT AND DIAPHYSEAL SEGMENT. THE TIBIAL COMPONENT WAS NOT REVISED. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457554 CPS SHORT ANCHOR PLUG 12MM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 037980 00880304461703

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R