BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGEN/RNGLC+ MULTI 56MM SZ 24

    MDR report key: 7837313 · Received August 31, 2018

    Report

    Report Number
    0001825034-2017-10934
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    February 12, 2016
    Report Date
    September 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK070369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: CAT#22-300916; LOT#379520 - ARCOS 16X190MM SPL TPR DIST HA; CAT#650-0840; LOT#2754109 - 36MM COCR BIOMET FEM HD -3 NK; CAT#PT-106056; LOT#389700 - REGEN/RNGLC+ MULTI 56MM SZ 24; CAT#EP-105894; LOT#427480 - RINGLOC 36MM EPOLY LNR 10 DEG SZ24; CAT#350806; LOT#283490 - 2.0 MM SS CABLE/SLEEVE COMBO; CAT#350806; LOT#203530 - 2.0 MM SS CABLE/SLEEVE COMBO; CAT#350806; LOT#111410 - 2.0 MM SS CABLE/SLEEVE COMBO. 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. RELATED MFR REPORTS: 0001825034-2017-10931; 0001825034-2017-10932; 0001825034-2017-10934; 0001825034-2017-10935; 0001825034-2018-08664; 0001825034-2018-08665; 0001825034-2018-08666.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL RIGHT HIP SURGERY ON AN UNKNOWN DATE AND WAS REVISED DUE TO LOOSENING (B)(6) 2014. SUBSEQUENTLY PATIENT EXPERIENCED PROBLEMS WALKING ABOUT, PROBLEMS WASHING OR DRESSING, MODERATE PAIN (MAY TAKE ASPIRIN), A MODERATE LIMP, MODERATE TROUBLE GETTING IN OR OUT OF THE CAR, MODERATE DIFFICULTY PUTTING ON SOCKS, NOTED IT WAS IMPOSSIBLE TO SHOP, EXTREMELY DIFFICULT TO CLIMB STAIRS, MODERATELY PAINFUL TO STAND UP, AND UNABLE TO PERFORM USUAL ACTIVITIES AT 3 YEAR FOLLOW UP VISIT ON (B)(6) 2016. THE PATIENT WAS ALSO USING 2 CRUTCHES OR A WALKER AT THE 3 YEAR VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677457 REGEN/RNGLC+ MULTI 56MM SZ 24 PROSTHESIS - HIP LPH ZIMMER BIOMET, INC. N/A 389700

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other