BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC 133 T1 PPS SO

    MDR report key: 9587922 · Received January 14, 2020

    Report

    Report Number
    0001825034-2020-00224
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    January 6, 2020
    Report Date
    May 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    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: D10, H2, H3, H6, H10. EVALUATION OF THE RETURNED PRODUCT CONFIRMED THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED ITEMS IDENTIFIED NO DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED ISSUE DURING MANUFACTURING. THE LIKELY CONDITION OF THE PRODUCTS WHEN THEY LEFT ZIMMER BIOMET WAS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED AND/OR THE POROUS COATING TO SHED FROM THE IMPLANT. A CORRECTIVE ACTION WAS OPENED TO ASSESS ALL CURRENT STERILE BARRIER SYSTEMS USED TO PACKAGE PRODUCTS AT ZIMMER BIOMET BRIDGEND. AS PART OF THIS ACTION, THE POUCH IS BEING IMPROVED TO USE A STRONGER MATERIAL (NYLON), AND FOAM END CAPS ARE BEING ADDED. ALSO, THE ORIENTATION THE DEVICES ARE PACKED IN THE SHIPPER BOX IS MOVING FROM VERTICAL TO HORIZONTAL, AND THE THICKNESS OF THE SHIPPER BOX HAS BEEN INCREASED. UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IN THE STERILE PACKAGING MEETS THE ACCEPTABLE CRITERIA AND PRODUCT IS CONFORMING TO SPECIFICATIONS. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IS THE STERILE PACKAGING MEETS THE ACCEPTABLE CRITERIA SPECIFICATIONS. THIS EVENT IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC XR MP T1 PPS 15X115MM CAT# 51-145150 LOT# 6176135. TPRLC XR T1 PPS 17X154MM CAT# 51-105170 LOT# 3863579. TPRLC XR MP T1 PPS 16X117MM CAT# 51-145160 LOT# 2884154. TPRLC 133 MP TYPE1 PPS HO 11.0 CAT# 51-107110 LOT# 6037304. TPRLC 133 T1 PPS HO 10X140MM CAT# 51-104100 LOT# 3873496. TPRLC XR MP T1 PPS 12X109MM CAT# 51-145120 LOT# 3943861. 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 - 00218, 0001825034 - 2020 - 00219, 0001825034 - 2020 - 00220, 0001825034 - 2020 - 00221, 0001825034 - 2020 - 00222, 0001825034 - 2020 - 00223.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS FOUND WITHIN STERILE PACKAGES WHILE INVESTIGATING ITEMS AT THE DISTRIBUTORSHIP. THERE WAS NO PATIENT INVOLVEMENT. 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
    51925 TAPERLOC 133 T1 PPS SO PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 3791223

    Patients

    Seq Age Sex Outcome Treatment
    1