BEUDAMED
    FDA Adverse Event Death Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/LT-STER

    MDR report key: 6134661 · Received November 30, 2016

    Report

    Report Number
    1000562954-2016-10214
    Event Type
    Death
    Date Received
    November 30, 2016
    Report Date
    November 11, 2016
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JDP
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT WEIGHT IS NOT AVAILABLE FOR REPORTING. IT WAS REPORTED THAT AN OBESE, OSTEOPOROTIC (B)(6) PATIENT WITH A VARIABLE ANGLE LOCKING CONDYLAR PLATE (LCP) AND A CORTEX SCREW, BROKE POST-OPERATIVELY REQUIRING REVISION SURGERY. IT WAS REPORTED THAT THE ENTIRE REVISION SURGERY TOOK 4 HOURS. SUBSEQUENTLY, THE PATIENT PASSED AWAY A FEW HOURS AFTER THE REVISION SURGERY WAS COMPLETED. AT THE TIME OF THIS REVIEW, THERE WAS NO INFORMATION REGARDING CAUSE OF DEATH NOR CAUSAL RELATIONSHIP TO THE DEVICES, THEREFORE THIS WILL BE CONSERVATIVELY REPORTED AS POTENTIALLY RELATED TO SYNTHES DEVICE. DATE OF EVENT IS UNKNOWN. FAILURE OF IMPLANT REPORTEDLY OCCURED THE WEEK BEFORE REVISION ON (B)(6) 2016. ADDITIONAL DEVICE PRODUCT CODE: HRS AND HWC. (B)(4). DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. THERAPY DATE FOR CONCOMITANT DEVICES IS UNKNOWN. REPORTER CONTACT NUMBER (B)(6). (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 02.124.417S, LOT # 8999642. MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: JUN 12, 2014, EXPIRY DATE: JUN 01, 2024. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL IMPLANT PROCEDURE ON (B)(6) 2015. ON (B)(6) 2016, PATIENT UNDERWENT HIP REVISION PROCEDURE DUE TO A VARIABLE ANGLE LOCKING CONDYLAR PLATE (LCP) AND A CORTEX SCREW BREAKING POST-OPERATIVELY. DURING THE REVISION PROCEDURE, A NEW PLATE WITH LOCKING ATTACHMENT PLATES WAS IMPLANTED AND THE BROKEN CORTEX SCREW WAS REMOVED WITH AN EXTRACTION REAMER. THE REVISION PROCEDURE WAS ONLY PERFORMED DUE TO THE PLATE BREAKING ONE WEEK PRIOR TO (B)(6) 2016. THE SURGEON STATED THAT THE BREAKING OF IMPLANTS WAS POSSIBLY CAUSED BY THE INITIAL NON-UNION FRACTURE AND STRESS-RISER FROM THE CERCLAGE CABLE. THE ENTIRE REVISION SURGERY TOOK FOUR (4) HOURS. SUBSEQUENTLY, THE PATIENT PASSED AWAY FEW HOURS AFTER THE REVISION SURGERY WAS COMPLETED. CONCOMITANT REPORTED PART: POSITIONING PIN (PART # 298.803.01S, POSSIBLE LOT # 9488071 OR 9466078, QUANTITY: 1). CERCLAGE CABLE (PART 298.801.01S, POSSIBLE LOT # 8056572, 9433804, 9644265 OR 9633200, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/LT-STER. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787073 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/LT-STER IMPLANT,FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES MEZZOVICO 8999642

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R PART # 298.803.01S, LOT # UNKNOWN, QUANTITY: 1| PART 298.801.01S, LOT # UNKNOWN, QUANTITY: 1