BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTR HD 36MM T1 STD

    MDR report key: 7182857 · Received January 11, 2018

    Report

    Report Number
    0001825034-2018-00211
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    December 5, 2014
    Report Date
    March 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 11-107022, FREEDOM CONSTR. LINER +5 SZ 23, 046580. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED 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 - 2018 - 00210.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT - FREEDOM CONSTR. LINER +5 SZ 23 # ITEM 11-107022 LOT 046580; RNGLC+ LTD HOLE FIN SHL SZ50 # ITEM 16-104150 LOT 263080; OSS FINN MOD PROX FMRL RT 7CM # ITEM 150457 LOT 915480; OSS 13CM DIAPHYSEAL SEGMENT # ITEM 150469 LOT 315450; OSS 10CM TOTAL FEM DIAPH CPLR # ITEM 150462 LOT 718070; OSS TIBIAL POLY BEARING 12MM # ITEM 150410 LOT 289880; OSS 7CM SEGMENTAL FEMORAL RT # ITEM 150354 LOT 452790; OSS POLY TIBIAL BUSHING # ITEM 150476 LOT 226710; OSS POLY FEMORAL BUSHINGS 2PK # ITEM 150477 LOT 030400; OSS POLY LOCK PIN # ITEM 150478 LOT 241370; OSS AXLE # ITEM 150480 LOT 985130; OSS REINFORCED YOKE # ITEM 150493 LOT 085030. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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)(4). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25156 FREEDOM CONSTR HD 36MM T1 STD PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 829150

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R