BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 7064063 · Received November 28, 2017

    Report

    Report Number
    0001825034-2017-10589
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    March 21, 2017
    Report Date
    February 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: STERILE EXPIRY DATE, UNKNOWN, MANUFACTURE DATE, UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: TAPERLOC COMPLETE PRIMARY FEMORAL POROUS COATED STEM, CATALOG# 51-101160, LOT# 3595059; UNKNOWN CUP, CATALOG# UNK, LOT# UNK; UNKNOWN HEAD, CATALOG# UNK, LOT# UNK; UNKNOWN LINER, CATALOG# UNK, LOT# UNK; UNKNOWN TAPER, CATALOG# UNK, LOT# UNK. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD 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). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 10588, 0001825034-2017-04576, 0001825034 - 2017 - 10589, 0001825034 - 2017 - 10590, 0001825034 - 2017 - 10591. MEDICAL PRODUCTS: 110017104 G7 FINNED 4 HOLE SHELL 54F LOT 3703149. 51-100140 TPRLC 133 FP TYPE1 PPS SO 14.0 LOT 3722132. 010000858 G7 NEUTRAL E1 LINER 36MM F LOT 3794200. 650-1065 CER OPTION TYPE 1 TPR SLEVE -3 LOT 843120. 650-1057 CER BIOLOXD OPTION HD 36MM LOT 100590. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS LIMPING AND HAS TROUBLE WEIGHT BEARING STATUS POST RIGHT TOTAL HIP ARTHROPLASTY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842686 UNKNOWN LINER PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3794200

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other