BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM TI STRAIGHT RADIAL STEM 28MM-STERILE

    MDR report key: 6272628 · Received January 24, 2017

    Report

    Report Number
    2520274-2017-10256
    Event Type
    Injury
    Date Received
    January 24, 2017
    Report Date
    January 4, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    K112030
    Removal / Correction Number
    Z-1124-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. PART NUMBER IS EITHER 04.402.008S OR 04.402.009S. THIS REPORT IS FOR UNKNOWN UNK - RADIAL STEM/UNKNOWN LOT NUMBER. QUANTITY IS EITHER ONE OR TWO. NOT EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE 510K#: COULD BE K112030. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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)(6). (B)(4). THE REPORTED EVENT HAS CAUSED OR CONTRIBUTED TO THE NEED FOR MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICES WERE EXPLANTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART #: 04.402.008S, LOT#: 7917023 (STERILE) - 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE, QUANTITY (B)(4): MANUFACTURING LOCATION: SUPPLIER (B)(4), PACKAGED BY: (B)(4), MANUFACTURING DATE: 11-MAY-2015, EXPIRATION DATE: 30-APR-2020. INSPECTION SHEET FOR INCOMING FINAL INSPECTION MEETS SPECIFICATION. RAW MATERIAL LOT NUMBER 7557656 REVIEWED. RAW MATERIAL PROVIDED BY (B)(4). (B)(4) PRODUCT CERTIFICATION MEETS SPECIFICATION. NO NON CONFORMANCE REPORTS (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. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THE INVESTIGATION HAS CONFIRMED THAT THESE IMPLANTS ARE SUBJECTED TO DELIVERY STOP AND THE PARTS ARE CONSEQUENTLY BLOCKED IN THE SYSTEM. IN ADDITION, ON 30 DECEMBER 2016 SYNTHES (B)(4) HAS INITIATED A VOLUNTARY MEDICAL DEVICE REMOVAL (RECALL) OF THE DEPUY SYNTHES RADIAL HEAD PROSTHESIS SYSTEM DUE TO THE POSSIBILITY THAT THE RADIAL STEM MAY LOOSEN POST-OPERATIVELY AT THE STEM BONE INTERFACE (B)(4). THE PARTS ARE NOT RETURNED. NO FURTHER INVESTIGATION COULD BE PERFORMED. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS REVIEWED AND DETERMINED TO BE A PART OF RECALL. 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 THE SURGEON MENTIONED HE HAD A LOOSENING OF THE RADIAL HEAD PROSTHESIS. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THIS COMPLAINT INVOLVES 2 PARTS. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT WAS OPERATED ON (B)(6) 2016 FOR AN OPEN REDUCTION AND OSTEOSYNTHESIS OF THE RIGHT RADIAL HEAD FOR A MULTI-FRAGMENTARY MASON III FRACTURE. LATER ON THE PATIENT WAS IMPLANTED ON (B)(6) 2016 WITH RADIAL HEAD PROSTHESIS FOR OPEN POST-REDUCTION STATUS AND OSTEOSYNTHESIS OF A MASON IV FRACTURE OF THE RIGHT RADIAL HEAD WITH PLATE, WITH EARLY WEAR DOWN. THE REMOVAL OF THE RADIAL HEAD PROSTHESIS TOOK PLACE ON (B)(6) 2017 BECAUSE THE RIGHT RADIAL PROSTHETIC HEAD BECAME UNSEALED. OVER TIME, THE PROSTHESIS SHOWED AN OSTEOLYSIS. AN ELBOW PUNCTURE WAS POSITIVE FOR PROPIONBACTERIUM ACNES (STERILE PRIMOCULTURES, GROWTH AFTER ENRICHMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57516 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 7917023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention