BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW Ø6,5 H.45MM

    MDR report key: 12745768 · Received November 3, 2021

    Report

    Report Number
    3008021110-2021-00084
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 18, 2021
    Report Date
    May 16, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K172456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DHR OF THE SCREW LOT #2006430, NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS PLACED ON THE MARKET WITH THE SAME LOT #. BY CHECKING THE DHR OF THE INVOLVED LOT #2014390, NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS PLACED ON THE MARKET WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT REPORTED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED BONE SCREW LOT #2006430 - STER. 2000241, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) OUT OF (B)(4) BONE SCREWS WITH LOT #2006430 - STER. 2000241 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED ACETABULAR CUP LOT #2014390 - STER. 2000302, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 8 OUT OF (B)(4) ACETABULAR CUPS WITH LOT #2014390 - STER. 2000302 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. ITEMS ANALYSIS THE METAL DEBRIS AND TWO OF THE THREE THREADED PLUGS OF THE ACETABULAR CUP HAVE BEEN RECEIVED BY LIMACORPORATE FOR FURTHER ANALYSIS. THE MATERIAL COMPOSITION OF THE METAL DEBRIS WAS TESTED TO GAIN INSIGHT ON ITS ORIGIN. A SEM (SCANNING ELECTRON MICROSCOPY) ANALYSIS WAS CONDUCTED, AND IT REVEALED THAT THE DEBRIS ARE MADE BY TITANIUM ALLOY. TRACES OF OXYGEN AND CARBON WERE FOUND AS WELL, COMPATIBLE WITH THE CONTAMINATION COMING FROM THE ORGANIC MATERIAL THEY CAME IN CONTACT WITH, AND WITH THE SUBSEQUENT PROCESS OF OXIDATION. BONE SCREWS AND ACETABULAR CUPS ARE MADE IN TI6AL4V, THUS THE METAL DEBRIS CAME OUT OF THESE IMPLANTS. NO OBSERVATIONS WERE REPORTED ON NOTICING THE DEBRIS WHEN THE ITEMS WERE TAKEN OUT OF THE POUCHES. AS ABOVE STATED, UPON CHECKS OF DEVICE HISTORY RECORDS NO ANOMALIES WERE FOUND ON THE MANUFACTURING PROCESSES OF THE INVOLVED LOT #S. IN ADDITION, IT WOULDN'T HAVE BEEN FEASIBLE TO UNSCREW THE THREADED PLUGS IF METAL DEBRIS WERE PRESENT ON THEM. IT IS REASONABLE TO SPECULATE THAT THE DEBRIS GENERATED OUT OF THE ACETABULAR CUP DURING SURGERY. INDEED, DEBRIS WERE NOTED JUST UPON SCREW INSERTION. IT IS POSSIBLE THAT WHILE DRILLING THE SCREW HOLES AFTER IMPACTION OF THE ACETABULAR CUP, THE TIP OF THE DRILL MIGHT HAVE BEEN USED EXCESSIVELY TILTED, TOUCHING THE EDGES OF THE CUP WITH THE SHARPING PART, GENERATING THE DEBRIS. SCREWING IN THE BONE SCREWS LED TO THE EXTRACTION OF SUCH DEBRIS. CONSIDERING THAT: CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #2006430 AND #2014390; THE TESTS PERFORMED ON THE RETURNED METAL DEBRIS REVEALED THAT THEY ARE MADE BY TITANIUM ALLOY; WE CAN SPECULATE THAT DEBRIS GENERATED OUT OF THE ACETABULAR CUP DURING SURGERY WHILE DRILLING THE SCREW HOLES, INDEED THE DEBRIS WERE NOTED JUST WHILE PLACING THE BONE SCREWS IN; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA. ACCORDING TO OUR PMS DATA, THIS IS THE FIRST COMPLAINT REPORTING THE PRODUCTION OF METAL DEBRIS WHEN FIXATING THE DELTA PF ACETABULAR CUP, THUS WE CAN ESTIMATE THE OCCURRENCE RATE OF THE EVENT TO BE (B)(4)% (WW). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    DURING HIP SURGERY PERFORMED ON (B)(6) 2021, WHILE FIXING THE DELTA-PF ACETABULAR CUP Ø48 MM (PRODUCT CODE 5551.21.480, LOT #2014390 - STER. 2000302) WITH BONE SCREWS, METAL DEBRIS CAME OUT FROM THE CUP HOLES WHILE SCREWING THE BONE SCREW Ø6,5 H.45MM (PRODUCT CODE 8420.15.060, LOT #2006430 - STER. 2000241). IT WAS REPORTED THAT THE SURGEON REMOVED THE METAL DEBRIS FROM THE CUP HOLES. ACCORDING TO THE COMPLAINT SOURCE, THREE SCREWS WERE USED. IT WAS REPORTED THAT THE CUP AND THE SCREWS WERE IMPLANTED, AND FIXATION AND STABILITY WERE ASSESSED. NO ISSUES WERE REPORTED ON THE USED INSTRUMENTS. PATIENT IS A FEMALE, (B)(6). EVENT HAPPENED IN (B)(6).

    Description of Event or Problem · 0

    DURING HIP SURGERY PERFORMED ON (B)(6) 2021, WHILE FIXING THE DELTA-PF ACETABULAR CUP Ø48 MM (PRODUCT CODE 5551.21.480, LOT #2014390 - STER. 2000302) WITH BONE SCREWS, METAL DEBRIS CAME OUT FROM THE CUP HOLES WHILE SCREWING THE BONE SCREW Ø6,5 H.45MM (PRODUCT CODE 8420.15.060, LOT #2006430 - STER. 2000241). IT WAS REPORTED THAT THE SURGEON REMOVED THE METAL DEBRIS FROM THE CUP HOLES. ACCORDING TO THE COMPLAINT SOURCE, THREE SCREWS WERE USED. IT WAS REPORTED THAT THE CUP AND THE SCREWS WERE IMPLANTED, AND FIXATION AND STABILITY WERE ASSESSED. NO ISSUES WERE REPORTED ON THE USED INSTRUMENTS. PATIENT IS A FEMALE, 77 YEARS OLD. EVENT HAPPENED IN SOUTH KOREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640370 BONE SCREW Ø6,5 H.45MM BONE SCREWS DIA. 6.5 X H. 45 MM LPH LIMACORPORATE S.P.A. 8420.15.060 2006430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention