BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-MAX S STANDARD FEM. STEM #13

    MDR report key: 8172787 · Received December 18, 2018

    Report

    Report Number
    3008021110-2018-00120
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    November 27, 2018
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MEH
    PMA / PMN Number
    K160011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE STERILIZATION CHARTS: BY CHECKING THE STERILIZATION CHARTS OF THE LOT#S OF ALL THE COMPONENTS EXPLANTED, NO ANOMALY WAS FOUND ON THE OVERALL NUMBER OF COMPONENTS, THUS CONFIRMING THAT COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. ACCORDING TO THE INFO REPORTED, EXPLANTS WERE DISPOSED OF BY THE HOSPITAL. X-RAYS ANALYSIS: NO X-RAYS AVAILABLE. ADD INFO REPORTED: GERM IDENTIFIED WAS P ACNES. NOT KNOWN IF ANY PREVIOUS CASE OF INFECTION WAS EXPERIENCED BY THE PATIENT. CONCLUSION: WITH THE FEW INFO AVAILABLE (NO CLINICAL INFO ABOUT PREVIOUS INFECTION CASES REPORTED BY THE PATIENT), WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE INFECTION REPORTED. A DEEPER INVESTIGATION IS NOT POSSIBLE. ACCORDING TO THE CHECK OF THE STERILIZATION CHARTS, WE CAN ENSURE THAT COMPONENTS ORIGINALLY IMPLANTED ON 4TH OF DECEMBER 2012 HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. CASE NOT PRODUCT RELATED. PMS DATA: WE ARE AWARE OF A TOTAL OF 5 CASES OF INFECTION INVOLVING A H-MAX S STEM (STANDARD + LATERALIZED) BELONGING TO THE FAMILIES 4250.20.XXX-4251.20.XXX ON A TOTAL OF MORE THAN 50300 H-MAX S STEMS SOLD WW FROM 2009. SPECIFIC REVISION RATE IS VERY LOW (0.01%). NO CORRECTIVE ACTION FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE.

    Description of Event or Problem · 0

    FIRST STAGE HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2018. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2012 BY IMPLANTING THE FOLLOWING COMPONENTS: · H-MAX S STANDARD FEM. STEM #13 CODE 4250.20.130 LOT# 1112943 STER. 1100410; · FEM. MODULAR HEAD - M Ø32MM CODE 5010.09.322 LOT# 1208835 STER. 1200243; · DELTA-TT ACETAB.CUP Ø52 MM FOR CODE 5552.15.520 LOT# 1205762 STER. 1200180; · DELTA PROTR.LINER ØINT 32MM #M CODE 5886.51.158 LOT# 1204045 STER. 1200142; · BONE SCREW Ø6,5 H.25MM CODE 8420.15.020 LOT# 1205060 STER. 1200187. ACCORDING TO THE INFO REPORTED, DURING THE FIRST STAGE REVISION SURGERY ALL THE COMPONENTS HAVE BEEN REMOVED AND ONLY THE SPACER WAS PUT IN. NO INFO RECEIVED ABOUT A SECOND STAGE REVISION. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT#S NO ANOMALY WAS FOUND, THUS WE CAN STATE THAT THE COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    FIRST STAGE HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2018. PREVIOUS SURGERY PERFORMED ON (B)(6) 2012. DURING REVISION ALL THE COMPONENTS HAVE BEEN REMOVED AND SPACER PUT IN. THE COMPONENTS INVOLVED ARE THE FOLLOWING: H-MAX S STANDARD FEM. STEM #13 CODE 4250.20.130 LOT# 1112943 STER. 1100410; FEM. MODULAR HEAD - M Ø32MM CODE 5010.09.322 LOT# 1208835 STER. 1200243; DELTA-TT ACETAB.CUP Ø52 MM FOR CODE 5552.15.520 LOT# 1205762 STER. 1200180; DELTA PROTR.LINER ØINT 32MM #M CODE 5886.51.158 LOT# 1204045 STER. 1200142; BONE SCREW Ø6,5 H.25MM CODE 8420.15.020 LOT# 1205060 STER. 1200187. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013643 H-MAX S STANDARD FEM. STEM #13 H-MAX S STANDARD UNCEMENTED STEMS (TI6AL4V + HA) N.13 (MEH-JDIKWY) MEH LIMACORPORATE S.P.A. 4250.20.130 1112943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention