BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 7CM SEGMENTAL FEMORAL LT

    MDR report key: 7845423 · Received September 5, 2018

    Report

    Report Number
    0001825034-2018-08674
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 8, 2018
    Report Date
    November 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS- OSS DIAHPYSEAL SEGMENT, CATALOG # 150466, LOT # 956520. . COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT DETERMINED THAT THE SCREW HOLE IS MISSING THE COUNTERBORE AND HAS ROUGH EDGES. DIMENSIONAL ANALYSIS OF THE SCREW HOLE DETERMINED THAT IT IS UNDERSIZED AND NONCONFORMING TO THE PRINT. DIMENSIONAL ANALYSIS OF THE RETURNED SCREW DETERMINED THAT IT IS WITHIN SPECIFICATION. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING DEFICIENCY AS THE PRODUCT FEATURE WAS NOT MACHINED PER PRINT. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: OSS DIAH SEG LOCK SCREW SET, CATALOG # 150481, LOT # 291030. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. DURING THE PROCEDURE, THE LOCKING SCREW WOULD NOT INSERT INTO THE FEMORAL COMPONENT. A SECOND SCREW FROM A DIFFERENT SET WAS OPENED AND IT WOULD NOT INSERT AS WELL. A NEW FEMUR WAS THEN OPENED AND THE LOCKING SCREW COULD ASSEMBLE INTO THE IMPLANT. THIS MALFUNCTION RESULTED IN A DELAY OF THIRTY TO THIRTY-FIVE MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685928 OSS 7CM SEGMENTAL FEMORAL LT PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. NI 418590

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other