BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 32MM C

    MDR report key: 10494466 · Received September 4, 2020

    Report

    Report Number
    0001825034-2020-03433
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 6, 2020
    Report Date
    October 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A G7 HI-WALL E1 LINER 32MM C, PART # 010000925 FROM LOT 6074858, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION CONFIRMED THE SHELL AND LINER TO BE ASSEMBLED AT THE START OF THE EVALUATION. THE RIM OF THE LINER IS SCRATCHED. THE HIGH WALLED PORTION OF THE LINER THAT PROTRUDES BEYOND THE FACE OF THE SHELL IS SCRATCHED ON THE OUTSIDE. A SINGLE GOUGE IS PRESENT ON THE INNER RADIUS OF THE LINER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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

    (B)(4). REPORT SOURCE: FOREIGN: (B)(6). G7 PPS LTD ACET SHELL 48C, CAT# 010000661, LOT# 6532433. FEMORAL HEAD STERILE, CAT# 00801803202, LOT# 64349704. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-03432.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE OPERATION, THE DOCTOR FOUND THAT THE LINING COULD NOT BE INSERTED INTO THE ACETABULAR CUP. NO BONE DEBRIS, SOFT TISSUE OR FOREIGN MATTER WERE DETECTED BEFORE IMPLANTATION. THE LINING BECAME LOOSE, WHICH WAS STILL LOOSE AFTER REPEATED ATTEMPTS. FINALLY, DOCTORS REMOVE THE IMPLANTS FROM THE PATIENT'S BODY AND USE OTHER PRODUCTS TO COMPLETE THE OPERATION. THERE WAS A 20 MIN DELAY IN SURGERY. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957588 G7 HI-WALL E1 LINER 32MM C PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6074858

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR