BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKOWN CUP

    MDR report key: 7756590 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-06318
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    January 7, 2011
    Report Date
    September 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE IS TWO WEEKS PRIOR TO OFFICE VISIT ON (B)(6) 2011. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES PROVIDED. REVIEW OF THE OPERATIVE NOTES CONFIRM THAT TWO WEEKS PRIOR TO REVISION, PATIENT PRESENTED WITH ONGOING GROIN PAIN. A PSOAS INJECTION WAS PERFORMED AT THAT TIME. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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). CONCOMITANT MEDICAL PRODUCTS: EP-105994 - EPOLY 28MM RNGLC LNR ¿ 378780; 12-115122 - CER BIOLOXD MOD HD 36MM +3 NK ¿ 970930; EP-105994 - EPOLY 28MM RNGLC LNR ¿ 024200; 650-1067 - CER OPTION TYPE 1 TPR SLEVE +3 ¿ 171470; 650-1057 - CER BIOLOXD OPTION HD 36MM - 171090. THERAPY DATE: (B)(6) 2011. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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 PATIENT UNDERWENT ILIOPSOAS INJECTION APPROXIMATELY 7 MONTHS POST RIGHT TOTAL HIP ARTHROPLASTY DUE TO PAIN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599380 UNKOWN CUP PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R