BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 PPS LTD ACET SHELL 48C

    MDR report key: 10494458 · Received September 4, 2020

    Report

    Report Number
    0001825034-2020-03432
    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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D4, D10, G4, H2, H3, H6 COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A G7 PPS LTD ACET SHELL 48C, PART # 010000661 FROM LOT 6532433, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE SHELL AND LINER TO BE ASSEMBLED UPON THE START OF THE EVALUATION. NO ATTEMPTS WERE MADE TO DISASSEMBLE THE DEVICES. THE RIM OF THE LINER AND SHELL ARE FLUSH TO THE TOUCH AND VISUALLY APPEARS TO BE APPROPRIATELY SEATED. BONE CEMENT WAS OBSERVED ON THE SHELL'S OUTER RADIUS. 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: (B)(6). CONCOMITANT MEDICAL PRODUCTS: G7 HI-WALL E1 LINER 32 MM C CAT# 010000925 LOT# 6074858 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: 0001825034-2020-03433.

    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
    957252 G7 PPS LTD ACET SHELL 48C PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6532433

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR SEE H10 NARRATIVE