BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR MP FP T1 PPS 5X95MM T1

    MDR report key: 9763345 · Received February 27, 2020

    Report

    Report Number
    0001825034-2020-00890
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 12, 2020
    Report Date
    April 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQG
    PMA / PMN Number
    K120030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EVALUATION OF THE RETURNED PRODUCTS IDENTIFIED THAT THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. THE COMPLAINT HAS BEEN CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THESE PRODUCTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO TRANSIT DAMAGE CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED. THE EVENT IS BEING ADDRESSED THROUGH THE CAPA PROCESS. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 T1 PPS HO, 13X146MM 6MM T1, CAT#51-104130, LOT# 3799301. TPRLC XR MP T1 PPS, 15X115MM 115MM T1, CAT#51-145150, LOT#3577454. TPRLC XR MP T1 PPS, 14X113MM 113MM T1, CAT# 51-145140, LOT# 3150390. TPRLC XR MP T1 PPS, 16X117MM 117MM T1, CAT# 51-145160, LOT# 2920949. TPRLC XR MP T1 PPS, 16X117MM 117MM T1, CAT#51-145160, LOT#3011809. REPORT SOURCE: (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: 0001825034-2020-00886, 0001825034-2020-00887, 0001825034-2020-00888, 0001825034-2020-00889, 0001825034-2020-00891.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS FOUND WITHIN STERILE PACKAGES. NO PATIENTS WERE INVOLVED. 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
    226314 TPRLC XR MP FP T1 PPS 5X95MM T1 PROSTHESIS, HIP OQG ZIMMER BIOMET, INC. NI 3446162

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10