BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER 10 DEGREE 36 MM I.D. SIZE F

    MDR report key: 11057134 · Received December 22, 2020

    Report

    Report Number
    0001822565-2020-04197
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    December 16, 2020
    Report Date
    April 12, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D11: CATALOG#: 30113606 LINER 10 DEGREE 36 MM I.D. SIZE F FOR USE WITH G7 ACETABULAR SYSTEM ONLY LOT#: 64861735 CATALOG#: 110017105 G7 FINNED 4 HOLE SHELL 56F LOT#: 6857904 CATALOG#: 110003623 BIOLOX DELTA CER LNR 36MM F LOT#: 6681073 CATALOG#: 00877503602 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14 LOT#: 2933939 CATALOG#: 0106010006 AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 6, TAPER 12/14 LOT#: 3035499 CATALOG#: 010000998 G7 SCREW 6.5MM X 25MM LOT#: 6786157, QTY 2 CATALOG#: 010000999 G7 SCREW 6.5MM X 30MM LOT#: 6805788 THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: A1, A2, D4 (UDI), D11, E1, E2, E3, G4, G7, H2, H10

    Additional Manufacturer Narrative · 0

    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 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.

    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: CATALOG#: 30113606 LINER 10 DEGREE 36 MM I.D. SIZE F LOT#: 64861735; UNKNOWN SHELL. FOREIGN: (B)(6). 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: 0001822565-2020-04198.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE LINER WOULD NOT SEAT INTO THE SHELL. A CERAMIC INSERT WAS USED TO COMPLETE THE 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
    1521575 LINER 10 DEGREE 36 MM I.D. SIZE F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64878456

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR