BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS POLY TIBIAL BEARING 14

    MDR report key: 7943858 · Received October 8, 2018

    Report

    Report Number
    0001825034-2018-09192
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    August 23, 2018
    Report Date
    February 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCTS: OSS POLY TIBIAL BUSHING, CAT#: 150476, LOT#: 528280; OSS LOCK PIN, CAT#: 150478, LOT#: 0000165580; OSS SEGMENTAL STACKING ADAPTER, CAT#: 150483, LOT#: 604630; OSS REINFORCED YOKE, CAT#:150493, LOT#: 0000225345; COMPRESS ANCHOR PLUG 12 MM, CAT#: 178402, LOT#: 985030; CPS SMALL MED FORCE 12MM SPINDLE, CAT#: 178464, LOT#: 135760; COMPRESS NUT, CAT#: 178512, LOT#: 718380; TRANSVERSE PIN SET, CAT#: 178526, LOT#: 766880; COMPRESS 14MM CENTERING SLEEVE, CAT#: 178536, LOT#: 276440; CPS TAPER LOCKING CAP, CAT#: 178710, LOT#: 396730; 24MM TRANSVERSE PIN, CAT#: RD125061, LOT#: 019130; OSS RED EXP DSTL FEM LT ASSY, CAT#: CP111803, LOT#: 085120; OSS RS AXLE, CAT#: 161035, LOT#: 273130; OSS RS FEM BUSHINGS, CAT#: 161034, LOT#: 786860; OSS RS NON MOD TIB PLATE LONG, CAT#: 161039, LOT#: 211120. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08955 - 1, 0001825034-2018-09192.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTION AND ADDITIONAL INFORMATION. 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 A KNEE REVISION DUE A CUSTOM EXPANDABLE DEVICE FRACTURING; THE FRACTURE PIECE REPORTEDLY MIGRATED IN THE JOINT SPACE CAUSING THE TIBIAL BEARING TO BREAK LEADING TO WEAR AND METALLOSIS. THE EXPANDABLE DEVICE WAS REMOVED AND A HINGED FEMORAL SYSTEM WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION DUE A CUSTOM EXPANDABLE DEVICE FRACTURING; THE FRACTURE PIECE REPORTEDLY MIGRATED IN THE JOINT SPACE CAUSING THE TIBIAL BEARING TO BREAK LEADING TO WEAR AND METALLOSIS. THE EXPANDABLE DEVICE WAS REMOVED AND A HINGED FEMORAL SYSTEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782695 OSS RS POLY TIBIAL BEARING 14 PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 743310

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R