BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED DISTAL FEMORAL COMPONENT

    MDR report key: 7354297 · Received March 20, 2018

    Report

    Report Number
    0001825034-2018-02062
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    May 30, 2018
    Report Date
    July 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK043547
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS- OSS REINFORCED YOKE, CATALOG # 150493, LOT # 521950, OSS RS AXLE, CATALOG # 161035, LOT # 017400, OSS RS TIBIAL BEARING, CATALOG # 161094, LOT # 072250, OSS POLY FEMORAL BUSHING, CATALOG # 161034, LOT # 367570, OSS POLY BUMPER LOCK PIN, CATALOG # 367570, LOT # 150510, OSS POLY FEMORAL BUSHING, CATALOG # 161034, LOT # 148870, OSS TAPER ADAPTOR, CATALOG # 78548, LOT # 700520, OSS RS NON MOD PLATE SHORT, CATALOG # 161036, LOT # 159780, OSS POLY TIBIAL BUSHING, CATALOG # 150476, LOT # 324830, OSS POROUS IM STEM, CATALOG # 150382, LOT # 335190, QUICK DRILL STERILE 2PK, CATALOG # 32-486265, LOT # 221070. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE WAS RETURNED FOR REVIEW. VISUAL INSPECTION FOUND SCRATCHING ON THE INTERCALARY SEGMENT, COLLAR, AND REDUCED DISTAL BODY. THE REDUCED DISTAL BODY HAS ALSO BEEN GOUGED AS SEEN IN THE ATTACHED PHOTO. DEEP SCRATCHES WERE OBSERVED AT THE POINT THE INTERCALARY SEGMENT ENTERS THE COLLAR. THE THREADS OF THE REDUCED DISTAL BODY CAN BE VIEWED THROUGH THE HOLE IN THE COLLAR. THE VISIBLE THREADS ARE CHIPPED. IT IS NOTED THAT THE COLLAR THREADS ARE UNRELATED TO THE DEVICE BEING ABLE TO EXPAND. THE COLLAR IS USED TO HOLD THE EXPANDABLE DEVICE INSIDE THE DISTAL FEMORAL BODY. THE COMPLAINT DEVICE WAS FURTHER EXAMINED IN ORDER TO DETERMINE FAILURE MODE. A HEX DRIVER WAS USED TO TURN THE ADJUSTING SCREW AND IT FUNCTIONED AS INTENDED WITH LITTLE TO NO RESISTANCE. THE DEVICE WAS FURTHER DISASSEMBLED IN ORDER TO SEE IF THERE WAS ANY DAMAGE OR WEAR ON THE INNER THREADS THAT MAY HAVE CAUSED THE FAILURE THE SURGEON REPORTED. AFTER UNSCREWING THE COLLAR, THE EXPANDABLE PORTION WAS PULLED FROM THE DISTAL FEMORAL SEGMENT. THERE WAS SOME NOTED BIOMATERIAL ON THE EXPOSED THREADS OF THE ADJUSTABLE SLEEVE WHICH IS TO BE EXPECTED AFTER BEING IMPLANTED FOR NEARLY 5 YEARS. THE ADJUSTABLE SCREW WAS UNSCREWED FROM THE IC SEGMENT WITH LITTLE TO NO RESISTANCE FELT AND COULD BE UNSCREWED BY HAND AFTER A FEW TURNS WITH THE HEX DRIVER. THE MALE THREADS ON THE ADJUSTABLE SCREW AND THE FEMALE THREADS ON THE IC SEGMENT WERE BOTH EXAMINED AND DID NOT APPEAR TO SHOW SIGNS OF WEAR OR DEFORMATION. THERE WAS SOME BIOMATERIAL IN THE IC SEGMENT BUT THIS WAS BELOW WHERE THE FEMALE THREADS STOP; THEREFORE, THIS WOULD NOT HAVE CONTRIBUTED TO THE REPORTED EVENT. NO WEAR OR DEFORMATION WAS IDENTIFIED ON THE CLEANED DEVICE. THE ADJUSTABLE SCREW WAS ALSO PLACED ON A COMPARATOR TO LOOK AND AGAIN, NO DAMAGE COULD BE IDENTIFIED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE FUNCTIONED AS INTENDED UPON ITS RETURN. 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 · 1

    IT WAS REPORTED THAT DURING A REVISION KNEE ARTHROPLASTY THE DEVICE DID NOT EXPAND. THE PATIENT IS SCHEDULED FOR REVISION SURGERY.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE EXPANDABLE DISTAL FEMUR NOT EXPANDING. 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
    196807 RED DISTAL FEMORAL COMPONENT PROSTHESIS KNEE KWA ZIMMER BIOMET, INC. N/A 619770

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R