BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X38MM

    MDR report key: 7378210 · Received March 28, 2018

    Report

    Report Number
    0001825034-2018-02153
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    November 20, 2017
    Report Date
    January 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVISION OPERATIVE NOTES NOTE REVISION WAS DUE TO DISLOCATING/SUBLUXING RTH, FRACTURED POLY AND OSTEOLYSIS OF THE ACETABULUM. BONE GRAFTING OF CAVITY DEFECTS WAS PERFORMED. OSTEOLYSIS WAS FOUND IN THE ISCHIUM PUBLIC AND RAMUS WITH METAL ON METAL TYPE SYNOVITS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ACTIVE ARTICULATION BEARING IS NOT COMPATIBLE WITH THE SHELL IMPLANTED IN A PREVIOUS SURGERY. AS THE SHELL WAS NOT REMOVED DURING THE 1ST REVISION PROCEDURE, USE OF THIS BEARING AND SHELL COMBINATION IS CONSIDERED TO BE OFF LABEL USE. IT CANNOT BE CONFIRMED THAT THIS INCOMPATIBILITY HAS ANY DEFINITIVE RELATIONSHIP TO THE REPORTED EVENT. WITH THE INFORMATION PROVIDED, A SPECIFIC CAUSE COULD NOT BE DETERMINED FOR THE REPORTED CONDITION. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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).MEDICAL DEVICES: 15-105050, M2A 1 PC SHELL 38MMX50MM, 993340; 12-115109, CER BIOLOXD MOD HD 28MM -3 NK, 2887244. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02152, 0001825034 - 2018 - 02154: PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED FIVE MONTHS POST-IMPLANTATION DUE TO SUBLUXATION AND OSTEOLYSIS IN THE ISCHIUM PUBIC AND RAMUS WITH METAL-ON-METAL TYPE SYNOVITIS, PAIN, AND DISCOMFORT. THE PATIENT WAS REVISED WITH REVISION ACETABULUM AND BONE GRAFTING OF CAVITY DEFECTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220205 ACT ARTIC E1 HIP BRG 28X38MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 270740

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R