BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS BOLT CONCENTRIC CLAMP

    MDR report key: 7431186 · Received April 13, 2018

    Report

    Report Number
    0001825034-2018-02638
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    January 5, 2018
    Report Date
    April 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CPS TIB SPINDLE 600LB WASH SET CATALOG # CP111171 LOT # 177680, TIBIAL ANCHOR SCREW X-SHORT CATALOG # CP160232 LOT # 190830, COMPRESS 10MM ANCHOR PLUG, CATALOG # RD125010, LOT # 753730, COMPRESS NUT CATALOG # RD125050 LOT # 857550, 24MM TRANSVERS PIN 6PK, CATALOG # RD125061, LOT # 936690, 28MM TRANSVERS PIN 6PK, CATALOG # RD125062, LOT # 586820, FINN TIBIAL BUSHING CATALOG # 153851 LOT # 979030, FINN FEMORAL BUSHING SET OF 2 CATALOG # 153852 LOT # 908440, FINN AXLE CATALOG # 153872 LOT # 938140, FINN MOD TIBIAL BEARING STD 12 CATALOG # 153982 LOT # 364260, FINN LOCK PIN CATALOG # 153861 LOT # 818380, COMPRESS (TM) PROXIMAL TIBIAL BASE CATALOG # CP111193 LOT # 156210, FINN ROTATING HINGE YOKE/LONG REINFORMENT CATALOG # 153866 LOT # 821610, FINN ROTATING HINGE YOKE MODULAR RESURFACING FEMORAL CATALOG # 153802 LOT # 634170, RAMIREZ HICO TIBIAL SPINDLE POROUS CATALOG # CP110352 LOT # 194060, COMPRESS LIGAMENT ANCHOR WASHER WITH SCREW CATALOG # CP160110 LOT # 178510, FINN ROTATING HINGE MODULAR FEMORAL/TIBIAL STEM CATALOG # 153816 LOT # 687360. IMPLANT DATE: (B)(6) 2001. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034 -2017 -11259, 0001825034 -2018 -01750, 0001825034-2018-02633, 0001825034-2018-02636, 0001825034-2018-02641, 0001825034-2018-02644. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF X-RAYS INDICATES RADIOLUCENT LINES AT FEMORAL COMPONENT CEMENT-BONE INTERFACE, WHICH IS PROBABLY INDICATIVE OF LOOSENING OF THE FEMORAL COMPONENT. PERMEATIVE RADIOLUCENCIES AND AGGRESSIVE PERIOSTEAL REACTION INVOLVING THE ANTERIOR CORTEX OF THE MID TIBIAL SHAFT (ANTERIOR TO THE DISTAL TIBIAL COMPRESS DEVICE) ARE MOST LIKELY DUE TO OSTEOMYELITIS OR NEOPLASTIC PROCESS. ALSO A SCREW PROJECTS OVER THE SOFT TISSUES POSTERIOR LATERAL TO THE PROXIMAL TIBIAL COMPONENT AT THE LEVEL OF THE PROXIMAL METAPHYSIS WHICH IS OF UNCERTAIN ORIGIN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE REMAINS UNABLE TO BE DETERMINED; HOWEVER, IT IS NOTED THAT THE PATIENT IS INCARCERATED AND UNABLE TO FOLLOW PROPER REHAB PROTOCOLS. 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 · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE LOOSENING OF THE HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273304 COMPRESS BOLT CONCENTRIC CLAMP PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 189940

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R