BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR T1 PPS 15X150MM MM T1

    MDR report key: 9917227 · Received April 2, 2020

    Report

    Report Number
    0001825034-2020-01459
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 11, 2020
    Report Date
    July 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K120030
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; G4; H2; H3; H4; H6 UPON VISUAL INSPECTION ALL SIX BOXES HAVE LOOSE WHITE DEBRIS IN THE CLEAR PACKAGING. THE STERILE BARRIER HAS NOT BEEN BROKEN. THE DEVICE HISTORY RECORDS FOR ITEM # 51-105150, LOT # 2931354 WERE REVIEWED FOR DEVIATIONS AND / OR ANOMALIES WITH THE FOLLOWING ANOMALIES / DEVIATIONS IDENTIFIED: NCR177707 WAS WRITTEN TO ADD THE CHECK OF SECTION D-D TO IDENTIFY NON-CONFORMANCE AT THE EARLIEST OPPORTUNITY. NCR163814 WAS WRITTEN FOR MARKS AND SCRATCHES ON THE NECK AND NECK FLATS WITH TWELVE PIECES REWORKED. NCR1301131911 WAS WRITTEN FOR POOR POLISH WITH TWELVE PIECES REWORKED. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IT LIKELY TO BE DAMAGE DURING TRANSIT CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED. THE DEVICE EVALUATION FOUND NO MALFUNCTION AND THE EVENT DID NOT CONTRIBUTE TO INJURY, THEREFORE THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT. 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 ADDITIONAL INFORMATION ON REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE INVESTIGATING CIRCULATED ITEMS IN STOCK, MANY OF THE ITEMS HAD DEBRIS IN THE STERILE PACKAGING. 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
    379882 TPRLC XR T1 PPS 15X150MM MM T1 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 2931354

    Patients

    Seq Age Sex Outcome Treatment
    1