BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREWS

    MDR report key: 18958955 · Received March 22, 2024

    Report

    Report Number
    3008021110-2024-00025
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    February 28, 2024
    Report Date
    September 23, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K172456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF MANUFACTURING CHARTS OF LOT NUMBERS INVOLVED. THIS IS THE FIRST COMPLAINT RECEIVED ON THE LOT NUMBERS INVOLVED. WE WILL SUBMIT A FINAL REPORT AFTER THE FINAL INVESTIGATION.

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF MANUFACTURING CHARTS OF LOT NUMBERS INVOLVED. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES MANUFACTURED WITH LOT. 1600986 HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES MANUFACTURED WITH LOT. 2114220 HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES MANUFACTURED WITH LOT. 2105840 - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES MANUFACTURED WITH LOT. 2114898 - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. THE EXPLANTED DEVICES WERE RECEIVED AT LIMACORPORATE FOR FURTHER INVESTIGATION. FROM A VISUAL EXAMINATION WE CAN CONFIRM THE REPORTED EVENT, BREAKAGE OF BONE SCREWS AND HEMISPHERIC MODULE. ONE PRE-REVISION X-RAY, DATED (B)(6) 2024, HAS BEEN RECEIVED FROM THE COMPLAINT SOURCE AND EVALUATED BY A MEDICAL CONSULTANT, WITH THE FOLLOWING COMMENT: "THE SENT X-RAY ONLY SHOWS A COMPLETELY DISLOCATED CUP WITH SOME BROKEN SCREWS. FROM THAT I CANNOT SAY ANYTHING ABOUT A POSSIBLE FAILURE. ANALYSIS SHALL BE POSSIBLE AS SOON AS YOU SEND AS MANY FOLLOW UPS AS POSSIBLE SINCE (B)(6) 2021 [?]. OF COURSE A CUP CANNOT TURN IN THAT WAY IF WELL INTEGRATED. HOWEVER, WITHOUT ADDITIONAL X-RAYS IT IS IMPOSSIBLE TO SAY WHEN THE LOOSENING STARTED. I WOULD SUSPECT THE CUP WAS NOT VERY STABLE FROM THE BEGINNING, BUT THIS CANNOT BE PROVEN WITHOUT IMAGING." EVEN THOUGH REQUESTED, THE POST-OP FOLLOW-UP X-RAYS SINCE (B)(6) 2021, HAVE NOT BEEN PROVIDED BY THE COMPLAINT SOURCE. THEREFORE, BASED ON THE INFORMATION AVAILABLE WE SUPPOSE THAT THE CUP WAS NOT WELL STABLE/INTEGRATED FROM THE BEGINNING, AND IT GOT LOOSE. WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, CONSIDERING THAT: - THE DHRS OF LOT NUMBERS INVOLVED IN THE EVENT DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALY. - ACCORDING TO THE MEDICAL CONSULTANT A CUP CANNOT TURN IN THAT WAY IF WELL INTEGRATED. HOWEVER, WITHOUT ADDITIONAL X-RAYS IT IS IMPOSSIBLE TO SAY WHEN THE LOOSENING STARTED. I WOULD SUSPECT THE CUP WAS NOT VERY STABLE FROM THE BEGINNING, BUT THIS CANNOT BE PROVEN WITHOUT IMAGING WE MAY CLASSIFY THE EVENT AS NOT PRODUCT RELATED. PRODUCT FAMILY ANALYSIS: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF TT HEMISPHERIC MODULES - BELONGING TO THE FAMILY CODES (B)(4) - DUE TO BREAKAGE IS (B)(4). 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. THIS IS A FINAL MDR REPORT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO BREAKAGE OF BONE SCREWS AND HEMISPHERIC MODULE, WITH LOOSENING OF ACETABULAR CUP. THE FOLLOWING DEVICES WERE EXPLANTED: · TT HEMISPHERIC MODULE Ø50 MM (PRODUCT CODE: 5533.14.500, LOT. 1600986 - STER. 2100173) - NOT SOLD IN US · DELTA-ONE-TT ACETAB.CUP Ø50MM (PRODUCT CODE: 5549.14.501, LOT. 2114220 - STER. 2100253) - NOT SOLD IN US · BONE SCREW Ø6,5 H.50MM (8420.15.070, LOT. 2105840 - STER. 2100141) · BONE SCREW Ø6,5 H.50MM (8420.15.070, LOT..2114898 - STER. 2100236) PREVIOUS SURGERY PERFORMED ON (B)(6) 2021. PATIENT AGE: 26 YEARS OLD EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO BREAKAGE OF BONE SCREWS AND HEMISPHERIC MODULE, WITH LOOSENING OF ACETABULAR CUP. THE FOLLOWING DEVICES WERE EXPLANTED: · TT HEMISPHERIC MODULE Ø50 MM (PRODUCT CODE: 5533.14.500, LOT. 1600986 - STER. (B)(4)) - NOT SOLD IN US. · DELTA-ONE-TT ACETAB.CUP Ø50MM (PRODUCT CODE: 5549.14.501, LOT. 2114220 - STER. (B)(4)) - NOT SOLD IN US. · BONE SCREW Ø6,5 H.50MM (8420.15.070, LOT. 2105840 - STER. (B)(4)). · BONE SCREW Ø6,5 H.50MM (8420.15.070, LOT. 2114898 - STER. (B)(4)). PREVIOUS SURGERY PERFORMED ON (B)(6) 2021. PATIENT AGE: 26 YEARS OLD. EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563149 BONE SCREWS BONE SCREWS DIA. 6.5 X H. 50 MM LPH LIMACORPORATE S.P.A. 8420.15.070 2105840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention