BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X40MM

    MDR report key: 12085580 · Received June 29, 2021

    Report

    Report Number
    0001825034-2021-01916
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    May 27, 2021
    Report Date
    October 12, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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

    (B)(4). CONCOMITANT MEDICAL DEVICES: CAT#650-1064 CER OPTION TYPE 1 TPR SLEVE -6 LOT#2900788; CAT#650-1055 CER BIOLOXD OPTION HD 28MM LOT#2898728. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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 - 2021 - 01917.

    Description of Event or Problem · 1

    IT WAS REPORTED THE E1 ACTIVE ARTICULATION BEARING OF THE G7 DUAL MOBILITY WAS IMPLANTED IN THE PATIENT APPROXIMATELY 3 YEARS AND 8 MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS SUSPECTED OF HAVING IPD WHEN HE UNDERWENT MANUAL REDUCTION APPROXIMATELY 1 MONTH AGO DUE TO THE HEAD BEING REMOVED FROM THE E1AA BEARING. HOWEVER, IT WAS CONFIRMED THAT THE BEARING HAD COME OFF THE CUP DURING THE REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982175 ACT ARTIC E1 HIP BRG 28X40MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 783390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R