BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 17.0 1

    MDR report key: 9721848 · Received February 18, 2020

    Report

    Report Number
    0001825034-2020-00767
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    February 3, 2020
    Report Date
    June 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K110400
    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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED THERE WAS DEBRIS INSIDE THE STERILE PACKAGING THAT IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER AND BLACK DEBRIS CONSISTENT WITH POROUS MATERIAL FROM THE DEVICE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 AND POROUS MATERIAL FROM DEVICE TO BECOME ABRADED AND SHED. 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). CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 T1 PPS SO 13X146MMTP: CAT# 51-103130, LOT# 6067708. TPRLC 133 MP TYPE1 PPS HO 15.0: CAT# 51-107150, LOT# 6252490. TPRLC XR MP T1 PPS 14X113MM 113MM T1: CAT# 51-145140, LOT# 3810264. TPRLC XR MP T1 PPS 16X117MM 117MM T1: CAT# 51-145160, LOT# 3863578. TPRLC 133 T1 PPS HO 12X144MM 4MM T1: CAT# 51-104120, LOT# 3150202. REPORT SOURCE: FOREIGN COUNTRY: (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: 0001825034-2020-00763, 0001825034-2020-00764, 0001825034-2020-00765, 0001825034-2020-00766, 0001825034-2020-00768.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS FOUND WITHIN STERILE PACKAGES WHILE INVESTIGATING CIRCULATED ITEMS. NO HOSPITALS 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
    186361 TPRLC 133 MP TYPE1 PPS SO 17.0 1 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 2780770

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10