BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM (OSS) YOKE

    MDR report key: 6643412 · Received June 15, 2017

    Report

    Report Number
    0001825034-2017-04007
    Event Type
    Injury
    Date Received
    June 15, 2017
    Report Date
    October 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). MEDICAL PRODUCT ¿ OSS REINFORCED YOKE, CAT#: 150493 LOT#: 971970, OSS POLY BUMPER LOCK PIN, CAT#: 150510 LOT#: 281520, OSS AXLE, CAT#: 150480 LOT#: 168980, OSS TIBIAL POLY BEARING 16 MM, CAT#: 150412 LOT#: 130400, OSS POLY FEMORAL BUSHINGS 2PK, CAT#: 150477 LOT#: 570690, OSS 7 CM SEG ELLIPT FEMORAL RT, CAT#: 150356 LOT#: 408600, OSS NON-MOD TIB PLATE LONG 71, CAT#: 161043 LOT#: 851940, OSS CEMENTED IM STEM 1, CAT#: 150366 LOT #: 121850. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [PRODUCTS RETAINED BY HOSPITAL] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04066, 0001825034-2017-04067, 0001825034-2017-04068, 0001825034-2017-04069, 0001825034-2017-04070, 0001825034-2017-04071. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE VISUAL AND DIMENSION INSPECTION WAS NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. COMPATIBILITY CHECK IDENTIFIED NO ISSUES. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE SYSTEM REVISION PROCEDURE DUE TO INFECTION. IT IS UNKNOWN HOW LONG POST-OPERATIVELY THE INFECTION OCCURRED, HOWEVER IT WAS UNDER ONE YEAR POST-OPERATIVELY. ALL COMPONENTS WERE REMOVED, EXCEPT FOR THE IM STEM, AND REPLACED WITH CEMENT SPACERS. THE PATIENT UNDERWENT A RE-IMPLANTATION PROCEDURE APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426172 ORTHOPEDIC SALVAGE SYSTEM (OSS) YOKE PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 971970

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R