BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 18X190MM SPL TPR DIST HA

    MDR report key: 7320857 · Received March 7, 2018

    Report

    Report Number
    0001825034-2018-01517
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    January 9, 2015
    Report Date
    August 31, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 22-301343 ARCOS CON SZ C STD 80MM HA 854650, 22-300918 ARCOS 18X190MM SPL TPR DIST HA 176110, 120002 COCR TROCH CABLE 2.0MMX750MM 008130, 120010 COCR CABLE/SLEEVE SET 2.0MM 900490, 650-0873 32MM COCR BIOMET FEM HD +3 NK 3123536, 11-302144 ARCOS LATERAL TROCH BOLT 44MM 566380, 00625006515 BONE SCR 6.5X15 SELF-TAP 62566993, 00625006520 BONE SCR 6.5X20 SELF-TAP 62256199, 00625006520 BONE SCR 6.5X20 SELF-TAP 62748069, 00625006540 BONE SCR 6.5X40 SELF-TAP 62440464, UNK DOUBLE MOBILITY AVANTAGE CUP, UNK DOUBLE MOBILITY AVANTAGE INSERT. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. 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. 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. MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034 - 2018 - 01516, 0001825034 - 2018 - 08605, 0001825034 - 2018 - 08607.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY. SUBSEQUENTLY, THE PATIENT EXPERIENCED WOUND DEHISCENCE. PATIENT WAS TREATED WITH DEBRIDEMENT, CULTURES, AND PROPHYLACTIC ANTIBIOTICS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4) MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034-2018-01516, 0001825034-2018-01518. (B)(6). 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 FURTH ER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN CLINICAL STUDY (B)(6) THE PATIENT HAD WOUND DEHISCENCE POST OP. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164316 ARCOS 18X190MM SPL TPR DIST HA PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 176110

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O| R 22-301343 ARCOS CON SZ C STD 80MM HA LOT 854650| 650-0873 32MM COCR FEM HD +3 NK LOT 3123536| 22-301343 ARCOS CON SZ C STD 80MM HA LOT 854650| 650-0873 32MM COCR FEM HD +3 NK LOT 3123536