BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSICA PS TIBIAL LINER #4

    MDR report key: 10885298 · Received November 23, 2020

    Report

    Report Number
    3008021110-2020-00105
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    November 11, 2020
    Report Date
    March 5, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JWH
    PMA / PMN Number
    K152008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DHR OF THE LOT #2013988 (TIBIAL PLATE) AND #19BC02V (TIBIAL LINER), NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE OVERALL COMPONENTS MANUFACTURED WITH THESE LOT #S. FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE INVESTIGATED DEEPER THE ISSUE REPORTED. IN DETAILS, IT WAS PERFORMED A DIMENSIONAL ANALYSIS ON A COMPONENT BELONGING TO THE SAME LOT NUMBERS OF THE ONE INVOLVED IN THE COMPLAINT AVAILABLE IN HQ WAREHOUSE (COMPONENT INVOLVED IN THE COMPLAINTS WERE NOT AVAILABLE TO BE RETURNED TO LIMA HQ). SPECIFICALLY, A DIMENSIONAL ANALYSIS WAS PERFORMED ON: PHYSICA PS TIBIAL LINER #4 (6535.50.411, LOT# 19BC02V). NO ANOMALIES WERE DETECTED FOR THE ITEM. COMPONENT WAS DEMONSTRATED TO BE FULLY COMPLIANT TO THE SPECIFICS. THUS, WE CAN EXCLUDE THAT THE INTRA-OPERATIVE ISSUE REPORTED WAS PRODUCT RELATED. IT SHOULD BE UNDERLINED THE BLACK MARKS ON THE TIBIAL PLATE ARE INTENDED FOR THE CORRECT ALIGNMENT OF THE DEFINITIVE COMPONENT TO THE TRIAL COMPONENT. THE MARKS ON THE TIBIAL PLATE SHOULD NOT BE USED AS REFERENCE TO DETERMINE THE POSITIONING OF THE LINER. AS PER LIMA SURGICAL TECHNIQUE, THOSE MARKS ARE INTENDED FOR THE CORRECT POSITIONING OF THE TIBIAL PLATE RELATIVE TO THE TRIAL TIBIAL PLATE BY MARKING THE BONE. CONSIDERING THE CHECK OF THE MANUFACTURING CHARTS OF THE INVOLVED LOT #S, THE LACK OF SIMILAR COMPLAINTS ON THE SAME LOT NUMBERS, AND THE DIMENSIONAL ANALYSIS PERFORMED ON THE COMPONENT OF THE SAME LOT # INVOLVED IN THE COMPLAINT, WE CAN EXCLUDE THE EVENT TO BE PRODUCT-RELATED. AT THIS STAGE, WE CAN ONLY SPECULATE THAT ASSEMBLING PROBLEMS EXPERIENCED INTRA-OPERATIVELY COULD HAVE POSSIBLY BEEN AROSE FROM TISSUE DEBRIS THAT GOT ON THE PLATE DURING SURGERY. PMS DATA: ON THE BASIS OF OUR PMS DATA, THE OCCURRENCE RATE OF INTRA-OP PRODUCT MALFUNCTIONING INVOLVING PHYSICA PS TIBIAL CEMENTED PLATES WITH CODES 6522.15.XXX AND TIBIAL LINERS WITH CODES 6535.50.XXX IS VERY LOW (B)(4). NO CORRECTIVE ACTIONS IMPLEMENTED DUE TO THIS SPECIFIC CASE. LIMACORPORATE WILL KEEP THE MARKET MONITORED. NOTE: THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    DURING KNEE SURGERY PERFORMED ON (B)(6) 2020, AFTER IMPLANTING THE PHYSICA FIXED TIBIAL PLATE #4 (PRODUCT CODE 6522.15.040, LOT# 2013988 - STER. 2000308), SURGEON TRIED TO ASSEMBLE THE PHYSICA PS TIBIAL LINER #4 (PRODUCT CODE 6535.50.411, LOT# 19BC02V - STER. 2000072), BUT THE CENTERS OF THE TWO COMPONENTS WERE NOT ALIGNED. ACCORDING TO THE COMPLAINT SOURCE, ASSEMBLING WAS FINE, BUT THE SURGEON WAS UNSURE WHETHER THE TWO COMPONENTS WERE CORRECTLY POSITIONED. EVENT HAPPENED IN SOUTH KOREA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #2013988 AND #19BC02V, NO PRE-EXISTING ANOMALIES WERE DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THESE LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING KNEE SURGERY PERFORMED ON (B)(6) 2020, AFTER IMPLANTING THE PHYSICA FIXED TIBIAL PLATE #4 (PRODUCT CODE 6522.15.040, LOT# 2013988 - STER. (B)(4)), SURGEON TRIED TO ASSEMBLE THE PHYSICA PS TIBIAL LINER #4 (PRODUCT CODE 6535.50.411, LOT# 19BC02V - STER. (B)(4)), BUT THE CENTERS OF THE TWO COMPONENTS WERE NOT ALIGNED. ACCORDING TO THE COMPLAINT SOURCE, ASSEMBLING WAS FINE, BUT THE SURGEON WAS UNSURE WHETHER THE TWO COMPONENTS WERE CORRECTLY POSITIONED. EVENT HAPPENED IN (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347434 PHYSICA PS TIBIAL LINER #4 PS LINER #4 - H. 11 JWH LIMACORPORATE S.P.A. 6535.50.411 19BC02V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other