BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 54-F PPS LIMITED ACETABULAR SHELL

    MDR report key: 6908723 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07705
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    May 18, 2017
    Report Date
    January 5, 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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MULTIPLE MDR¿S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 07704, 0001825034 - 2017 - 07705. CONCOMITANT- 192013 ECHO POR FMRL NC 13X145MM LOT# 751010; 010000664 G7 PPS LTD ACET SHELL 54F LOT# 3790818; 650-1161 DELTA CER FEM HD 32/+3MM T1 LOT# 2016021417; 110003619 BIOLOX DELTA CER LNR 32MM F LOT# 3230050. (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA CLINICAL OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED FASCIA RUPTURE. THE PATIENT SUBSEQUENTLY UNDERWENT A PROCEDURE FOR SUTURE OF FASCIA. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688217 G7 54-F PPS LIMITED ACETABULAR SHELL PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3790818

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R