BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD - M Ø32MM

    MDR report key: 8929993 · Received August 26, 2019

    Report

    Report Number
    3008021110-2019-00093
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    August 14, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR CHECK: NO PRE-EXISTING ANOMALY WAS FOUND BY CHECKING THE DHRS OF THE ONLY LIMA COMPONENT THAT WAS EXPLANTED (FEMORAL HEAD CODE 5010.09.322; LOT# 1102849). WE CAN THEREFORE STATE THAT THIS COMPONENT WAS MANUFACTURED UP TO SPECS, NO DEVIATION DETECTED. FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 30 OUT OF 40 FEMORAL HEADS MANUFACTURED WITH THE SAME CODE/LOT# HAVE BEEN IMPLANTED AT TODAY WITHOUT RECEIVING ADDITIONAL COMPLAINTS ON THEM. EXPLANTS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE. X-RAYS ANALYSIS: WE RECEIVED ONE PRE-OP X-RAY (EXACT DATE UNKNOWN) AND WE SENT IT TO OUR MEDICAL CONSULTANT FOR A PROPER CLINICAL EVALUATION. HIS COMMENTS AS PER FOLLOWS: "THE X-RAY SHOWS A LOOSENED CUP (NOT MANUFACTURED BY LIMA) WITH AN OTHERWISE CORRECTLY IMPLANTED STEM (MAYBE THE PREVIOUS SURGEON HAS IMPLANTED A BIT TOO DEEP BUT THAT CERTAINLY WAS IN ACCORDANCE WITH THE THEN GIVEN CIRCUMSTANCES). A FINDING THAT MAYBE ATTRIBUTED TO THE CUP BUT THIS IS NOT IN LIMA'S RESPONSIBILITY. THE LOOSENED CUP HAS BEEN EXCHANGED. IT IS QUITE COMMON THAT, AFTER SUCH PROCEDURE, THE STABILITY OF THE HIP (AGAINST DISLOCATION) IS NOT GIVEN AS BEFORE. IN THAT CASE IT IS A USUAL PROCEDURE TO CORRECT THAT CONDITION BY EXCHANGING THE HEAD TO A ONE WITH A LONGER NECK LENGTH AND /OR MORE OFFSET. THIS IS A VERY ORDINARY PROCEDURE AND OBVIOUSLY ALSO WAS DONE BY THE SURGEON. IT DOES NOT MEAN THERE WAS A FAILURE OF THE HEAD (EXPLANTS DO NOT SHOW ANY IRREGULARITY) BUT IT SIMPLY WAS NOT LONG ENOUGH FOR THE NEW CONDITION. SEEMINGLY THE SURGEONS WERE SUCCESSFUL WITH THEIR INTERVENTION, SUCH NO REASON FOR COMPLAINING." CONCLUSION: ACCORDING TO OUR ANALYSIS, BASED ON THE INFO REPORTED BY THE COMPLAINT SOURCE AND CONFIRMED BY THE MEDICAL CONSULTANT'S OPINION, THE CAUSE FOR REVISION IS NOT RELATED TO ANY KIND OF ISSUE WITH LIMA FEMORAL HEAD. THE FEMORAL HEAD WAS IN FACT EXCHANGED IN ORDER TO GUARANTEE A CORRECT JOINT TENSIONING AFTER THE NON LIMA ACETABULAR CUP REPLACEMENT (ORDINARY PROCEDURE, ACCORDING TO OUR MEDICAL EXPERT'S REMARK). CAUSE FOR REVISION IS THEREFORE ONLY RELATED TO THE LOOSENING/SHIFT OF THE ACETABULAR CUP AND THE LIMA FEMORAL HEAD WAS REPLACED SOLELY TO ADJUST TO THE NEW JOINT CONDITION. PMS DATA: WE ARE NOT AWARE OF OTHER SIMILAR COMPLAINTS (FEMORAL HEADS WITH CODES 5010.09.XXX USED IN COMBINATION WITH COMPETITOR'S CUP AND REPLACED JUST TO ADAPT TO A NEW JOINT CONFORMATION AFTER THE REPLACEMENT OF THE CUP). ACCORDING TO OUR RECORDS, MORE THAN (B)(4) FEMORAL HEADS (CODES 5010.09.XXX) HAVE BEEN SOLD WW SINCE 2005, MEANING A VERY LOW SPECIFIC REVISION RATE OF (B)(4). NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT. NOTE: THIS IS AN INITIAL-FINAL COMBINED MDR AS ALL THE AVAILABLE INFO HAVE ALREADY BEEN RECEIVED AND ANALYSED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2019. ACCORDING TO THE INFO RECEIVED, THE MAIN REASON FOR REVISION WAS TO REPLACE THE ACETABULAR CUP WHICH WAS NOT MANUFACTURED BY LIMA. FEMORAL HEAD MANUFACTURED BY LIMA - CODE 5010.09.322; LOT# 1102849 - WAS REVISED TO INCREASE LENGTH AND OFFSET. OUR COMPLAINT SOURCE REPORTED THAT THE ACETABULAR CUP NEEDED TO BE REPLACED AS IT HAD BECOME LOOSE AND WAS SITTING OUT OF PLACE IN THE PATIENT'S ACETABULUM. THE LIMA FEMORAL HEAD, INSTEAD, NEEDED TO BE REPLACED TO INCREASE LENGTH AND OFFSET BECAUSE THE PATIENT'S ACETABULUM HAD INCREASED BONE LOSS, AS A CONSEQUENCE, THE NEW CUP THAT WAS IMPLANTED, SAT IN A SLIGHTLY DIFFERENT POSITION THAN THE ORIGINAL PRIMARY CUP AND, TO REGAIN JOINT TENSION, IT WAS NECESSARY TO INCREASE THE LENGTH AND OFFSET OF THE HEAD TO RESTORE PROPER JOINT FUNCTIONALITY. PREVIOUS SURGERY TOOK PLACE IN 2012. DURING THAT SURGERY, A LIMA REVISION STEM HAD BEEN IMPLANTED DUE TO A PERIPROSTHETIC FRACTURE. IT WAS A REVISION OF A COMPETITOR'S STEM, WHEREAS THE COMPETITOR'S CUP WAS LEFT IN SITU (PRIMARY SURGERY DATE IS UNKNOWN). DURING LAST REVISION (THE ONE PERFORMED ON (B)(6) 2019, OBJECT OF THIS REPORT) A LIMA MULTIHOLE TT CUP WAS IMPLANTED WITH SPACER AND LINER, AND THE FEMORAL HEAD WAS REPLACED WITH A 40MM CERAMIC HEAD WITH A XL OFFSET ADAPTER. PATIENT DATA: (B)(6) YEARS OLD, QUITE SEDENTARY. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723329 FEM. MODULAR HEAD - M Ø32MM MODULAR FEMORAL HEADS (COCRMO) DIA. 32MM M TAPER 12/14 (LPH-JDI-KWY-KWZ) LPH LIMACORPORATE S.P.A. 5010.09.322 1102849

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention