BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOW PROFILE RECON J-PLATE 16 HOLES-LEFT

    MDR report key: 12001164 · Received June 15, 2021

    Report

    Report Number
    8030965-2021-04951
    Event Type
    Injury
    Date Received
    June 15, 2021
    Report Date
    May 21, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER: 245.936. LOT NUMBER: 9955672. PART MANUFACTURE DATE: 15-DEC-2015. PART EXPIRATION DATE: N/A. NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICES HISTORY RECORD SHOW THIS LOT OF 3.5MM LOW PROFILE RECON PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL, AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS LOT MET ALL DIMENSIONAL, VISUAL, AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT HAD A LEFT ACETABULAR FRACTURE CAUSED BY A TRAFFIC ACCIDENT AND WAS TREATED WITH AN OPEN REDUCTION AND INTERNAL FIXATION. THE PATIENT WAS FOUND EXPERIENCING FEMORAL HEAD NECROSIS ON (B)(6) 2020. ON (B)(6) 2020 AN INTERNAL FIXATION AND REMOVAL UNDER GENERAL ANESTHESIA AND TOTAL HIP ARTHROPLASTY WAS PERFORMED. IT WAS FOUND THAT THE MORPHOLOGY OF THE FEMORAL HEAD WAS IRREGULAR DURING THE OPERATION. THE ORIGINAL INTERNAL FIXATION PLATE AND SCREW WERE REMOVED AND THE TOTAL HIP JOINT WAS USED FOR JOINT REPLACEMENT. THIS REPORT IS FOR ONE (1) 3.5MM LOW PROFILE RECON J-PLATE 16 HOLES-LEFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898550 3.5MM LOW PROFILE RECON J-PLATE 16 HOLES-LEFT PLATE, FIXATION, BONE HRS SYNTHES GMBH 9955672

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention