BEUDAMED
    FDA Adverse Event Injury Summary report: N

    26MM COCR RADIAL HEAD 4MM HT EXTENSION/17.5MM-STER

    MDR report key: 5201612 · Received November 4, 2015

    Report

    Report Number
    1719045-2015-10713
    Event Type
    Injury
    Date Received
    November 4, 2015
    Report Date
    October 21, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    PK112030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS PENDING COMPLETION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE RADIAL HEAD (PART 09.402.426 / LOT 6917191) AND THE RADIAL STEM (PART 04.402.029 / LOT 7013040) WAS LIKELY CAUSED BY AN INCORRECTLY SIZED IMPLANT OR PATIENT NONCOMPLIANCE; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE RADIAL HEAD AND RADIAL STEM ARE IMPLANTS ROUTINELY USED IN THE RADIAL HEAD PROSTHESIS SYSTEM. THE DEVICES WERE RETURNED AND REPORTED TO HAVE CAUSED PATIENT PAIN AND TO HAVE BECOME LOOSENED. THIS CONDITION IS UNCONFIRMED; THE IMPLANT WAS REMOVED FROM THE PATIENT AND X-RAYS WERE REVIEWED, BUT LOOSENING OF THE IMPLANT WAS INDISCERNIBLE SINCE ONLY PREOPERATIVE REVISION X-RAYS WERE PROVIDED. POSTOPERATIVE X-RAYS FROM THE ORIGINAL SURGERY WOULD BE NECESSARY TO COMPARE FOR LOOSENING OF THE IMPLANTS. IT IS LIKELY THAT AN INCORRECTLY SIZED IMPLANT OR PATIENT NONCOMPLIANCE HAS LED TO THIS COMPLAINT CONDITION. THE RADIAL HEAD WAS MANUFACTURED IN SEPTEMBER, 2012 AND IS OVER THREE YEARS OLD. THE RADIAL STEM WAS MANUFACTURED IN JANUARY, 2013 AND IS OVER TWO YEARS OLD. THE BALANCE OF THE RETURNED DEVICES IS IN FAIRLY WORN CONDITION CONSISTENT WITH IMPLANTATION AND REMOVAL. THE RELEVANT DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. NO DESIGN RELATED ISSUES WERE FOUND THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: SUPPLIER (B)(4), MONUMENT PKG., MANUFACTURING DATE: 9/14/2012, EXPIRATION DATE: 08/31/2017, PART #: 09.402.426S, LOT#: 6917191 (STERILE) - 26MM COCR RADIAL HEAD 4MM HT EXTENSION/17.5MM-STER - STERILE. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SCN 8738, ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ DEVICE WAS 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

    IT WAS REPORTED THAT A LEFT RADIAL PROSTHESIS HARDWARE REMOVAL WITH RESECTION PROCEDURE WAS PERFORMED ON (B)(6), 2015. THE ORIGINAL PROCEDURE TO REPAIR A LEFT RADIAL HEAD FRACTURE WAS PERFORMED ON (B)(6), 2014. SUBSEQUENTLY, THERE WAS NO BONY INGROWTH IN THE RADIAL CANAL. THE IMPLANT WAS LOOSE AND THE PATIENT EXPERIENCED PAIN UPON USE OF THE ARM FOR PUSHING AND LIFTING. THE RADIAL HEAD AND STEM HARDWARE WERE REMOVED FULLY INTACT AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. INFORMATION PERTAINING TO ANY SURGICAL DELAYS, PATIENT OUTCOMES, OR PROCEDURAL EVENTS IS UNKNOWN AS THE OPERATIVE REPORT IS NOT AVAILABLE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732710 26MM COCR RADIAL HEAD 4MM HT EXTENSION/17.5MM-STER PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 6917191

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention