BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD - M Ø32MM

    MDR report key: 15649218 · Received October 21, 2022

    Report

    Report Number
    3008021110-2022-00105
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    July 27, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS OF THE INVOLVED LOT NUMBERS WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY ON THE 100 FEM. MODULAR HEADS - M Ø32MM, PRODUCT CODE 5010.42.322, LOT N. 2183496, STER. 2100324 WAS DETECTED, NO PRE-EXISTING ANOMALY ON THE 6 DELTA-REVISION ACET.CUPS Ø50MM, PRODUCT CODE 5533.21.050, LOT N.1908345, STER.1900270 WAS DETECTED. THIS IS THE FIRST AND ONLY INCIDENT REGISTERED ON THESE LOT NUMBERS (2183496, 1908345). WE WILL SUBMIT A FINAL REPORT AFTER THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS OF THE INVOLVED LOT NUMBERS WERE CHECKED WITH THE FOLLOWING RESULTS: - NO PRE-EXISTING ANOMALY ON THE 100 FEM. MODULAR HEADS - M Ø32MM, PRODUCT CODE 5010.42.322, LOT N. 2183496, STER. 2100324 WAS DETECTED, - NO PRE-EXISTING ANOMALY ON THE 6 DELTA-REVISION ACET. CUPS Ø50MM, PRODUCT CODE 5533.21.050, LOT N.1908345, STER.1900270 WAS DETECTED. THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THESE LOT NUMBERS (2183496, 1908345). THE AVAILABLE X-RAYS IMAGES WERE ANALYZED BY A MEDICAL CONSULTANT, WITH THE FOLLOWING RESULT: "BOTH X-RAYS ARE DATED (B)(6) 2022, AT 15.32. AT LEAST ON X-RAY #1 DEFINITIVE LOOSENING OF THE CUP IS EVIDENT. ON BOTH XRAYS THE CUP DEFINITELY IS PLACED IN A WRONG POSITION, MUCH TOO VERTICAL WITH THE HOOK OUTSIDE THE POSITION IT IS SUPPOSED TO BE. THE AUGMENT IS NOT AT THE CORRECT POSITION. ADDITIONAL DISLOCATION SUCH IS NOT SURPRISING. AS THERE IS NO PREVIOUS XRAY I CANNOT COMMENT, WHETHER THE CUP HAS BEEN MISPLACED FROM THE BEGINNING (WHAT I WOULD SUSPECT) OR IT DISLOCATED DURING MOBILIZATION. PROBABLY A COMBINATION OF BOTH. ANYWAY REVISION IS REQUIRED, WITH CORRECTING THE OBVIOUS FAILURES." THE MEDICAL EXPERT ALSO NOTED THAT THE TWO X-RAYS ARE BOTH DATED (B)(6) 2022, BUT SHOW TWO DIFFERENT HIPS, ONE WITH WINGS, ANOTHER ONE WITHOUT AND THE STEMS APPEAR ALSO DIFFERENT IN THEIR POSITION. BOTH THE X-RAYS SHOWED HOWEVER A WRONG POSITIONING OF THE CUPS. NO FURTHER CLARIFICATIONS WERE AVAILABLE ABOUT THE X-RAYS/X-RAYS DATES PROVIDED BY THE COMPLAINT SOURCE. TO COMPLETE THE ANALYSIS, PREVIOUS X-RAYS WERE ALSO REQUESTED TO THE COMPLAINT SOURCE. X-RAYS TAKEN AFTER THE PREVIOUS SURGERY WERE RECEIVED AND SHARED WITH THE MEDICAL CONSULTANT. HE COMMENTED: "THE ADDITIONAL X-RAYS, DATED (B)(6), SEEM TO BE THE ONES PERFORMED IMMEDIATELY AFTER THE REVISION OF THE COMPETITORS IMPLANT, AS EVIDENCED BY THE VISIBLE DRAINAGE. ON THOSE X-RAYS IT IS CLEARLY VISIBLE, THAT THE CUP HAS BEEN PLACED IN A WRONG POSITION FROM THE VERY BEGINNING, WITH THE HOOK COMPLETELY OFF THE CORRECT POSITION. THERE ARE SOME WINGS VISIBLE, BUT OBVIOUSLY PARTIALLY REMOVED. THE CUP IS MUCH TO VERTICAL AND SUCH IT IS NOT SURPRISING THAT DISLOCATION OCCURRED AS VISUALIZED ON THE X-RAY DATED (B)(6) 2022. THIS MALPOSITION OF THE CUP HAS BEEN THE REASON FOR THE NEXT REVISION ON (B)(6)." THE INVOLVED DEVICES WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR ANALYSIS, THEREFORE NO SPECIFIC ANALYSIS COULD BE PERFORMED ON THEM. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION PERFORMED, WE CAN STATE THAT: - NO PRE-EXISTING ANOMALIES WERE DETECTED BY THE CHECK OF THE DEVICE HISTORY RECORDS, THUS THE COMPONENTS HAD BEEN MANUFACTURED UP TO SPECIFICATIONS AND IN LINE WITH THE RELEVANT CHECKS AND TESTS, - THE ANALYSIS OF THE X-RAYS TAKEN BEFORE THE REVISION SURGERY, CONFIRMED THAT THE ACETABULAR CUP APPEARS LOOSE AND IN A SUBOPTIMAL POSITION. THE ANALYSES OF THE X-RAYS TAKEN AFTER THE PREVIOUS SURGERY SUGGEST THAT THE ACETABULAR CUP WAS IN FACT IMPLANTED IN A SUBOPTIMAL POSITION. IN CONCLUSION, BASED ON THE ANALYSES PERFORMED, THE CAUSE OF THE REVISION SURGERY REPORTED DOES NOT SEEM TO BE PRODUCT-RELATED AND SURGICAL FACTORS MIGHT HAVE CONTRIBUTED. NOTE: THIS EVENT OCCURRED IN POLAND AND WAS REPORTED TO THE FDA AS THE FEMORAL HEAD IS MARKETED IN THE USA. HOWEVER, ACCORDING TO OUR ANALYSIS, THE MAIN CAUSE OF FEMORAL HEAD DISLOCATION IS RELATED TO THE POSITION OF THE CUP, WHICH IS NOT CLEARED IN THE USA. NO CORRECTIVE ACTION NEEDED FOLLOWING THIS COMPLAINT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    LEFT HIP REVISION SURGERY DUE TO DISLOCATION OF THE FEMORAL HEAD (FEM. MODULAR HEAD - M Ø32MM, PRODUCT CODE 5010.42.322, LOT N. 2183496, STER. 2100324) FROM ITS POSITION, PERFORMED ON (B)(6) 2022. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT FELT PAIN WHEN STANDING UP OF BED. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. THE COMPLAINT SOURCE REPORTED THAT THE SUSPECTED CAUSE IS AN INITIAL MIGRATION OF THE ACETABULAR CUP (DELTA-REVISION ACET.CUP Ø50MM, PRODUCT CODE 5533.21.050, LOT N.1908345, STER.1900270). PATIENT IS FEMALE, 40 YEARS OLD. THIS INCIDENT OCCURRED IN POLAND. THE PRODUCT CODE 5533.21.050 IS NOT MARKETED IN USA.

    Description of Event or Problem · 0

    LEFT HIP REVISION SURGERY DUE TO DISLOCATION OF THE FEMORAL HEAD (FEM. MODULAR HEAD - M Ø32MM, PRODUCT CODE 5010.42.322, LOT N. 2183496, STER. 2100324) FROM ITS POSITION, PERFORMED ON (B)(6) 2022. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT FELT PAIN WHEN STANDING UP OF BED. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022 AND WAS A REVISION SURGERY OF COMPETITOR'S IMPLANTS. THE COMPLAINT SOURCE REPORTED THAT THE SUSPECTED CAUSE IS AN INITIAL MIGRATION OF THE ACETABULAR CUP (DELTA-REVISION ACET.CUP Ø50MM, PRODUCT CODE 5533.21.050, LOT N.1908345, STER.1900270). PATIENT IS FEMALE, 40 YEARS OLD, BMI: 27.3, SEDENTARY. THIS EVENT OCCURRED IN POLAND. THE PRODUCT CODE 5533.21.050 IS NOT MARKETED IN USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927714 FEM. MODULAR HEAD - M Ø32MM BIOLOX DELTA HEAD 32MM #M LZO LIMACORPORATE S.P.A. 5010.42.322 2183496

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention