BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ D HI 80MM

    MDR report key: 8924905 · Received August 23, 2019

    Report

    Report Number
    0001825034-2019-03754
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    May 15, 2019
    Report Date
    September 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 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 SUBMITTED 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 SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DATE OF BIRTH: BORN IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: PART: 110024465, G7 DUAL MOBILITY LINER 46MM G, LOT: 143090, PART: 010000985, G7 FREEDOM CONST E1 LNR 36MM G, LOT: 6517058, PART: 11-300920, ARCOS 20X190MM SPL TPR DIST, LOT: 751510, PART: 010000666, G7 PPS LTD ACET SHELL 58G, LOT: 6320695, PART: 11-107018, FREEDOM CONSTR HD 36MM T1 STD, LOT: 062190, PART: 11-301354, ARCOS CON SZ D HI 80MM, LOT: 393990, PART: 010000997, G7 SCREW 6.5MM X 20MM, LOT: 6393349, PART: 010001002, G7 SCREW 6.5MM X 45MM, LOT: 6223759, PART: 010001001, G7 SCREW 6.5MM X 40MM, LOT: 6310209. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02567, 0001825034-2019-02568, 0001825034-2019-03752, 0001825034-2019-03754.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY, SUBSEQUENTLY THE PATIENT UNDERWENT A REVISION DUE TO RECURRENT DISLOCATION APPROXIMATELY FOUR WEEKS POST-IMPLANTATION. A REVIEW OF THE XRAYS NOTED HETEROTOPIC OSSIFICATION ALONG THE GREATER TROCHANTER AND LATERAL ASPECT THE PROXIMAL FEMORAL DIAPHYSIS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719581 ARCOS CON SZ D HI 80MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 393990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O