BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM RS AVL TIBIAL BUSHING SET

    MDR report key: 6783940 · Received August 10, 2017

    Report

    Report Number
    0001825034-2017-06163
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    July 11, 2017
    Report Date
    April 18, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. (B)(6).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL DEVICES: S POLY TIBIAL BUSHING CAT: 150476 LOT: 464690; OSS RS AVL 12MM YOKE CAT: CP0000535 LOT: 140590; 47MM OSS RS AVL TIB 8X70 STEM CAT: CP0000537 LOT: 140640; 7X70MM OSS CEMENTED STEM CAT: CP0000538 LOT: 150660; RS SIDE EXP DSTL FMRL LT 18CM CAT: CP114834 LOT: 074510; OSS POLY TIBIAL BUSHING CAT: 150476 LOT: 464690; OSS POLY LOCK PIN CAT: 150478 LOT: 835290; OSS RS POLY FEM BUSHINGS SET/2 CAT: 178548 LOT: 480230; OSS RS AXLE CAT: 161035 LOT: 177500; OSS RS 12MM LS TIBIAL BEARING CAT: 161094 LOT: 931150. INVESTIGATION REMAINS UNCHANGED. 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED BY REVIEWING THE PROCESSING OF THIS DEVICE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING DEFICIENCY AND OPERATOR ERROR.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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS BEING REVISED FOR UNKNOWN REASON, WHEN THE BOX WAS OPENED IN SURGERY IT ONLY CONTAINED THE TWO (2) LOCKING RINGS AND NONE OF THE BUSHINGS. THE SURGEON ULTIMATELY WAS ABLE TO COMPLETE THE SURGERY BY MODIFYING A STANDARD TIBIAL BUSHING TO MATE WITH THE REMAINING TIBIAL COMPONENTS. THE BUSHINGS MISSING FROM THE PACKAGING RESULTED IN A DELAY OF SURGERY IN EXCESS OF THIRTY (30) MINUTES. NO ADDITIONAL PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE BOX WAS OPENED IN SURGERY, IT ONLY CONTAINED THE TWO (2) LOCKING RINGS AND NONE OF THE BUSHINGS. THE SURGEON ULTIMATELY WAS ABLE TO COMPLETE THE SURGERY BY MODIFYING A STANDARD TIBIAL BUSHING TO MATE WITH THE REMAINING TIBIAL COMPONENTS. THE BUSHINGS MISSING FROM THE PACKAGING RESULTED IN A DELAY OF SURGERY IN EXCESS OF THIRTY (30) MINUTES. IT IS FURTHER REPORTED THAT A REVISION PROCEDURE TO REMOVE THE MODIFIED IMPLANTS WILL BE PERFORMED SOMETIME IN THE FUTURE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566949 ORTHOPEDIC SALVAGE SYSTEM RS AVL TIBIAL BUSHING SET PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 141220

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention