BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC OPTION TYPE 1 TAPER SLEEVE

    MDR report key: 6795893 · Received August 15, 2017

    Report

    Report Number
    0001825034-2017-05735
    Event Type
    Injury
    Date Received
    August 15, 2017
    Report Date
    November 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED DATE OF EVENT-EVENT DATE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: PART X180320 BI-METRIC/X POR NC LOT 434250, 650-1057 CER BIOLOXD OPTION HD 36 MMM LOT 243780, STRYKER ACETABULAR DOME HOLE PLUG CATALOG 2060-0000-1; STRYKER ACETABULAR LINER CATALOG 623-00-36G LOT 6K78PR; STRYKER ACETABULAR SHELL CATALOG 509-02-62G LOT P554TP; STRYKER BONE SCREW CATALOG 5260-5-030 LOT YJ1500; STRYKER BONE SCREW CATALOG 5260-5-030 LOT 53192401. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. IT IS REPORTED THAT A ZIMMER BIOMET HEAD WAS USED WITH THE REPORTED STRYKER PRODUCT DURING REVISION SURGERY. ZIMMER-BIOMET HAS NOT CONFIRMED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE PACKAGING INSERT. THE RECOMMENDED COMPATIBILITY CHART CAN BE FOUND AT WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM. HOWEVER, IT CANNOT BE CONFIRMED THAT THIS INCOMPATIBILITY HAS ANY DEFINITIVE RELATIONSHIP TO THE REPORTED EVENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    (B)(6). DATE OF EVENT - (B)(6) 2016. CONCOMITANT PRODUCTS: PART: 650-1057 NAME: CER BIOLOXD OPTION HD 36MM LOT: 243780. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-05736.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VEIN REMOVAL PROCEDURE DUE TO DEEP VEIN THROMBOSIS. NO PRODUCTS WERE REMOVED FROM THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574752 CERAMIC OPTION TYPE 1 TAPER SLEEVE PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 571420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization