BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RINGLOC LINER 10DEG22

    MDR report key: 7477488 · Received May 1, 2018

    Report

    Report Number
    0001825034-2018-02924
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    April 11, 2018
    Report Date
    June 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THROUGH VISUAL INSPECTION OF DEVICE, COMPLAINT WAS CONFIRMED AS VISUAL INSPECTION NOTED THE LINER EXHIBITED DAMAGE TO THE RECESSED AREAS AND WITNESS MARKS ARE SEEN ON THE OUTER DIAMETER OF THE LINER. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED DEVICES IDENTIFIED NO DEVIATIONS OR ANOMALIES. THE MOST LIKELY CAUSE OF THE EVENT IS DUE TO MISALIGNMENT OF THE LINER DURING THE LINER INSERTION; HOWEVER, ROOT CAUSE OF MISALIGNMENT IS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL/CORRECTED INFORMATION. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM#: 14-103646 UNIVERSAL 2 HOLE SHELL 46 MM LOT# 205240. (B)(6). DELAY IN SURGERY OVER 30 MINUTES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL THA APPROXIMATELY 4 MONTHS AGO. AFTER SURGEON IMPLANTED THE ACETABULAR CUP, HE EXPERIENCED ISSUES WITH SEATING THE LINER. SURGEON ATTEMPTED MULTIPLE TIMES TO SEAT LINER RESULTING IN USING ANOTHER PRODUCT LINER. SURGERY WAS DELAYED MORE THAN 30 MINUTES AND BLOOD LOSS INCREASED 1 UNIT . NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL THA APPROXIMATELY 4 MONTHS AGO. AFTER SURGEON IMPLANTED THE ACETABULAR CUP, HE EXPERIENCED ISSUES WITH SEATING THE LINER. SURGEON ATTEMPTED MULTIPLE TIMES TO SEAT LINER RESULTING IN USING ANOTHER PRODUCT LINER. SURGERY WAS DELAYED MORE THAN 30 MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320381 ARCOM 28MM RINGLOC LINER 10DEG22 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 865450

    Patients

    Seq Age Sex Outcome Treatment
    1 Other