BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 20X190MM SPL TPR DIST

    MDR report key: 8921486 · Received August 22, 2019

    Report

    Report Number
    0001825034-2019-03752
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    May 15, 2019
    Report Date
    September 18, 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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. XRAY REVIEW NOTES DISLOCATION OF THE FEMORAL HEAD AND POLYETHYLENE LINER, AND HETEROTOPIC OSSIFICATION ALONG THE GREATER TROCHANTER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    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. AGE OR DATE OF BIRTH: BORN IN (B)(6). UDI: (B)(4). 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, 0001825034-2019-03754.

    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 X-RAYS 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
    715144 ARCOS 20X190MM SPL TPR DIST PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 751510

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R