BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR T1 PPS 14X148MM

    MDR report key: 9677220 · Received February 6, 2020

    Report

    Report Number
    0001825034-2020-00536
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 27, 2020
    Report Date
    June 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K120030
    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: B4, B5, G4, H2, H3, H6 COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED PRODUCTS IDENTIFIED THAT THERE WAS DEBRIS INSIDE THE STERILE PACKAGING WHICH 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. 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 HO 12X144MM: CAT# 51-104120, LOT# 3727047. TPRLC133 MP T1 PPS SO 6X97.5MM: CAT# 51-108060, LOT# 2569203. TPRLC XR T1 PPS 17X154MM: CAT# 51-105170, LOT# 2844723. TPRLC 133 T1 PPS HO 13X146MM: CAT# 51-104130, LOT# 3714345. TPRLC 133 T1 PPS SO 15X150MM: CAT# 51-103150, LOT# 3262138. TPRLC 133 T1 PPS SO 15X150MM: CAT# 51-103150, LOT# 3386951. TPRLC XR T1 PPS 16X152MM: CAT# 51-105160, LOT# 2990162. TLOC 133 MP SP T1 PPSHO 6X97.5: CAT# 51-109060, LOT# 3433002. TPRLC 133 T1 PPS HO 16X152MM: CAT# 51-104160, LOT# 3219007. TPRLC 133 T1 PPS SO 10X140MM: CAT# 51-103100, LOT# 3446079. TPRLC 133 T1 PPS HO 17X154MM: CAT# 51-104170, LOT# 2525467. TPRLC 133 FP TYPE1 PPS HO 7.0 :CAT# 51-101070, LOT# 3354575. TPRLC XR T1 PPS 15X150MM: CAT# 51-105150, LOT# 2867459. TPRLC 133 FP TYPE1 PPS HO 6.0: CAT# 51-101060, LOT# 2552323. TPRLC 133 T1 PPS HO 15X150MM: CAT# 51-104150, LOT# 2563641. 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: 0001825034-2020-00534, 0001825034-2020-00535, 0001825034-2020-00537, 0001825034-2020-00538, 0001825034-2020-00539, 0001825034-2020-00540, 0001825034-2020-00541, 0001825034-2020-00542, 0001825034-2020-00543, 0001825034-2020-00544, 0001825034-2020-00545, 0001825034-2020-00546, 0001825034-2020-00547, 0001825034-2020-00548, 0001825034-2020-00549.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS IDENTIFIED IN STERILE PACKAGES. 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
    139587 TPRLC XR T1 PPS 14X148MM PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. NI 2931353

    Patients

    Seq Age Sex Outcome Treatment
    1