BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL MODULAR HEAD - M Ø36MM

    MDR report key: 19018057 · Received April 2, 2024

    Report

    Report Number
    3008021110-2024-00031
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    March 25, 2024
    Report Date
    April 22, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOTS #1900274 AND #1613854, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE 49 AND 10 COMPONENTS MANUFACTURED WITH THOSE LOT #S RESPECTIVELY. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THOSE LOT #S. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT #1900274, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE 49 COMPONENTS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 32 OUT OF 49 FEMORAL HEADS WITH LOT #1900274 AND STER. (B)(6) HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT #1613854, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE 10 COMPONENTS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 8 OUT OF 10 ANGLED SPACERS WITH LOT # 1613854 AND STER.(B)(6) HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS ANALYSIS DEVICES INVOLVED WERE NOT RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - DATED (B)(6) 2023 - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "ON THE SENT X-RAY NO DISLOCATION OF THE HEAD OUT OF THE LINER IS VISIBLE. HOWEVER, THE ANGLED SPACER IS NOT IN THE CORRECT POSITION, AND I HAVE THE IMPRESSION THAT IT HAS NOT BEEN FIXED CORRECTLY, LEADING TO DISLOCATION WITHOUT COMPLETE LUXATION. RESPECTIVE IMPINGEMENT MAY BE A CONSEQUENCE. EXCHANGE TO A DOUBLE MOBILITY VERSION HAS BEEN THE CORRECT ACTION IN THAT CASE. YOU SHOULD FIND OUT ABOUT THE FIXATION OF THE SPACER DURING REVISION". THE SURGEON RESPONSIBLE FOR THE REVISION SURGERY WAS DIFFERENT THAN THE SURGEON WHO PERFORMED THE PREVIOUS SURGERY. FURTHER DETAILS WERE ASKED TO THE COMPLAINT SOURCE ON THE FIXATION OF THE ANGLED SPACER. THE COMPLAINT SOURCE CONFIRMED THAT THE SURGEON RESPONSIBLE FOR THE REVISION SURGERY MENTIONED THAT THE SPACER MAY NOT HAVE BEEN FIXATED CORRECTLY AND THE ANGLE COULD BE OFF. IT WAS ALSO REPORTED THAT THE SPACER CAME OUT PRETTY EASILY DURING THE REVISION SURGERY. CONSIDERING THAT: · CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON DEVICES MANUFACTURED WITH LOTS #1900274 AND #1613854; · ACCORDING TO THE ACCORDING TO THE SURGEON THE PATIENT DIDN'T REQUIRE THE DELTA ANGLED SPACER 10° #XL+5, WHICH WAS CAUSING IMPINGEMENT AND DISLOCATION; · ACCORDING TO THE MEDICAL CONSULTANT "ON THE SENT X-RAY NO DISLOCATION OF THE HEAD OUT OF THE LINER IS VISIBLE. HOWEVER, THE ANGLED SPACER IS NOT IN THE CORRECT POSITION, AND I HAVE THE IMPRESSION THAT IT HAS NOT BEEN FIXED CORRECTLY, LEADING TO DISLOCATION WITHOUT COMPLETE LUXATION. RESPECTIVE IMPINGEMENT MAY BE A CONSEQUENCE"; · ACCORDING TO THE SURGEON RESPONSIBLE FOR THE REVISION SURGERY THE SPACER CAME OUT PRETTY EASILY DURING THE REVISION SURGERY AND IT MAY NOT HAVE BEEN FIXATED CORRECTLY; WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, BUT WE CAN HYPOTHESIZE IT WAS DUE TO A SUB-OPTIMAL CHOICE OF THE DEVICES AND EVENTUALLY TO THEIR IMPROPER ASSEMBLY. STILL, BASED ON THESE FINDINGS WE STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF FEMORAL HEAD - BELONGING TO THE FAMILY CODES 5010.09.XXX - DUE TO DISLOCATION IS (B)(4)%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6), 2024, DUE TO DISLOCATION OF THE FEMORAL MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.09.362, LOT #1900274 - STER. 1900095). IT WAS REPORTED THAT ACCORDING TO THE SURGEON THE PATIENT DIDN'T REQUIRE THE DELTA ANGLED SPACER 10° #XL+5 WHICH WAS CAUSING IMPINGEMENT AND DISLOCATION. THE FOLLOWING COMPONENTS GOT EXPLANTED: FEMORAL MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.09.362, LOT #1900274 - STER. 1900095). DELTA ANGLED SPACER 10° #XL+5 (PRODUCT CODE 5886.15.605, LOT #1613854 - STER. 1800099) - PRODUCT NOT SOLD IN THE US. DELTA NEUTRAL LINER ØINT 36MM #L (PRODUCT CODE 5885.51.260, LOT #1812434 - STER. 1800265). A NEUTRAL SPACER AND A DUAL MOBILITY LINER WERE IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2019. ACCORDING TO THE RECEIVED INFORMATION, THE PRIMARY SURGERY WAS PRIOR TO 2019 WITH COMPETITOR'S IMPLANTS. IN 2019, THE PATIENT UNDERWENT A REVISION TO EXPLANT COMPETITOR'S DEVICES AND IMPLANT LIMA DEVICES (REASON UNKNOWN). PATIENT IS A MALE. NO CLINICAL DETAILS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION OF THE FEMORAL MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.09.362, LOT #1900274 - STER. (B)(6)). IT WAS REPORTED THAT ACCORDING TO THE SURGEON, THE PATIENT DIDN'T REQUIRE THE DELTA ANGLED SPACER 10° #XL+5, WHICH WAS CAUSING IMPINGEMENT AND DISLOCATION. THE FOLLOWING COMPONENTS GOT EXPLANTED: · FEMORAL MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.09.362, LOT #1900274 - STER. (B)(6)) · DELTA ANGLED SPACER 10° #XL+5 (PRODUCT CODE 5886.15.605, LOT #1613854 - STER. (B)(6)) - PRODUCT NOT SOLD IN THE US · DELTA NEUTRAL LINER ØINT 36MM #L (PRODUCT CODE 5885.51.260, LOT #1812434 - STER. (B)(6)). A NEUTRAL SPACER AND A DUAL MOBILITY LINER WERE IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. ACCORDING TO THE RECEIVED INFORMATION, THE PRIMARY SURGERY WAS PRIOR TO 2019 WITH COMPETITOR'S IMPLANTS. IN 2019, THE PATIENT UNDERWENT A REVISION TO EXPLANT COMPETITOR'S DEVICES AND IMPLANT LIMA DEVICES (REASON UNKNOWN). PATIENT IS A MALE. NO CLINICAL DETAILS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566677 FEMORAL MODULAR HEAD - M Ø36MM MODULAR FEMORAL HEADS (COCRMO) DIA. 36MM M TAPER 12/14 LPH LIMACORPORATE S.P.A. 5010.09.362 1900274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other