BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGEN/RNGLC+ SOLID 62MM SZ 25

    MDR report key: 7406236 · Received April 9, 2018

    Report

    Report Number
    0001825034-2018-01270
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    April 24, 2014
    Report Date
    February 21, 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
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: EP-105915, EPOLY 36MM RNGLC LNR HW SZ25, 428790; 650-1130BMRSA, PRMRS NCK STEM TI BM SZ 30 RSA, 2459536; 650-0888, 36MM 12/14 TPR FEM HD STD NK, 3011115. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR PART PT-104062 LOT 038830 WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WHICH FOUND 1 PIECE SCRAPPED AT (B)(4). REVIEW OF THE DEVICE HISTORY RECORD FOR PART EP-105915 LOT 428790 IDENTIFIED NO DEVIATIONS OR ANOMALIES. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01271. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON THE RIGHT HIP. SUBSEQUENTLY, SIX MONTHS POST OP IT WAS REPORTED THAT THE PATIENT EXPERIENCED MILD TO MODERATE PAIN AND A SLIGHT LIMP THAT REQUIRED FREQUENT USE OF A CANE AND SOME PROBLEMS WITH PERFORMING USUAL ACTIVITIES. DURING THE ONE YEAR POST OP VISIT, THE PATIENT REPORTED MODERATE TO SEVERE PAIN AND HAD MODERATE DIFFICULTIES IN PERFORMING USUAL ACTIVITIES, EXTREMELY DIFFICULTY PUTTING ON SOCKS, AND PAIN THAT GREATLY INTERFERRED WITH USUAL WORK. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252512 REGEN/RNGLC+ SOLID 62MM SZ 25 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 038830

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention