BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD - L Ø36MM

    MDR report key: 8004678 · Received October 25, 2018

    Report

    Report Number
    3008021110-2018-00094
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    October 3, 2018
    Report Date
    August 28, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LPH
    PMA / PMN Number
    K112158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF STERILIZATION CHARTS: BY CHECKING THE STERILIZATION CHARTS OF ALL THE INVOLVED LOT#S, NO PRE-EXISTING ANOMALY WAS FOUND, MEANING THAT COMPONENTS HAD BEEN CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: NO EXPLANTS AVAILABLE TO BE RETURNED TO LIMACORPORATE. X-RAYS ANALYSIS: WE RECEIVED ONLY ONE PRE-OP X-RAY REFERRING TO REVISION SURGERY (EXACT DATE UNKNOWN). WE ASKED FOR A MEDICAL OPINION ABOUT WHAT RECEIVED. FOLLOWING, THE MEDICAL CONSULTANT'S JUDGMENT RECEIVED: "THE HIP APPEARS IMPLANTED CORRECTLY, NO MECHANICAL FAILURE IS DESCRIBED OR VISIBLE. THE "EVENT" SEEMS TO BE LIMITED TO THE INFECTION, WHICH IS A RARE BUT POSSIBLE COMPLICATION THAT MAY OCCUR IN SOME 2% OF CASES. ASSUMING THERE HAS NOT BEEN ANY GROSS NEGLIGENCE FROM THE SIDE OF THE SURGERY OR STERILIZATION OF IMPLANTS NOBODY CAN BE BLAMED FOR THAT. I ONLY HAVE DOUBTS THAT THE CHOSEN TREATMENT FOR REVISION MAY BE SUCCESSFUL IN ELIMINATING THE INFECTION. EXCHANGE ONLY OF LINER AND HEAD MAY HAVE SOME CHANCE OF ELIMINATING THE INFECTION WITHIN THE FIRST 3 WEEKS AFTER PRIMARY SURGERY - AFTER 12 WEEKS RECURRENCE MUST BE EXPECTED. HOWEVER, THIS SEEMS TO BE ANOTHER ISSUE THAT IS NOT UNDER DISCUSSION IN THAT CONTEXT". BY OUR SIDE, NO ADDITIONAL INFO RECEIVED ABOUT A POSSIBLE INFECTION EXPERIENCED AFTER THE REVISION SURGERY OF (B)(6) 2018. WE DO NOT RECEIVED INFO RELATED TO PATIENT'S CLINICAL DATA, ANY PREVIOUS INFECTION, GERM RESPONSIBLE FOR THE INFECTION. WE DO NOT HAVE SPECIFIC INFO ABOUT WHERE THE INFECTION WAS LOCATED (ONLY ACETABULAR SIDE? BOTH ACETABULAR AND FEMORAL SIDE?). WITH THE ONLY FEW INFO RECEIVED AND BASED ON OUR ANALYSIS, WE CANNOT ESTIMATE A CERTAIN ROOT CAUSE FOR THE INFECTION REPORTED. BY OUR STERILIZATION CHARTS CHECK, ALL THE COMPONENTS IMPLANTED ON (B)(6) 2018 HAVE BEEN CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. CASE NOT PRODUCT RELATED. PMS DATA: WE ARE AWARE OF A TOTAL OF 8 HIP REVISION SURGERIES DUE TO INFECTION INVOLVING COCR FEMORAL HEADS ON A TOTAL OF MORE THAN 119000 COCR FEMORAL HEADS CODE 5010.09.XXX/5012.09.XXX SOLD WW FROM 1994. SPECIFIC REVISION RATE OF (B)(4). NONE OF THE COMPLAINTS REPORTED WERE CLASSIFIED AS PRODUCT RELATED. WE ARE AWARE OF A TOTAL OF 6 HIP REVISION SURGERIES DUE TO INFECTION INVOLVING A DELTA NEUTRAL LINER ON A TOTAL OF 38550 DELTA NEUTRAL LINERS CODE 5885.51.XXX SOLD FROM 2007, GIVING A SPECIFIC REVISION RATE OF (B)(4). NONE OF THE COMPLAINTS REPORTED WERE CLASSIFIED AS PRODUCT RELATED. NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON THE (B)(6) 2018. PREVIOUS SURGERY TOOK PLACE ON THE (B)(6) 2018: THE FOLLOWING COMPONENTS HAD BEEN IMPLANTED: H-MAX S LATERAL. FEM. STEM #10 CODE 4251.20.100 LOT# 1801697 STER. 1800091; FEM. MODULAR HEAD - L Ø36MM CODE 5010.09.363 LOT# 1707859 STER. 1700274; DELTA-TT ACETAB.CUP Ø54 MM FOR CODE 5552.15.540 LOT# 1715448 STER. 1800053; DELTA NEUTR. LINER ØINT 36MM #L CODE 5885.51.260 LOT# 1801318 STER. 1800063. DURING REVISION SURGERY, ONLY FEMORAL HEAD AND LINER HAVE BEEN REPLACED AFTER A CLEAN OUT. SURGEON HAPPY WITH THE FINAL STABILITY OF THE IMPLANT. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF ALL THE INVOLVED LOT #S NO ANOMALY WAS FOUND, MEANING THAT THESE COMPONENTS HAD BEEN CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WILL INVESTIGATE FURTHER AND SUBMIT A FINAL MDR ONCE CONCLUDED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2018. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2018: THE FOLLOWING COMPONENTS HAD BEEN IMPLANTED: H-MAX S LATERAL. FEM. STEM #10 CODE 4251.20.100 LOT# 1801697 STER. 1800091; FEM. MODULAR HEAD - L Ø36MM CODE 5010.09.363 LOT# 1707859 STER. 1700274; DELTA-TT ACETAB.CUP Ø54 MM CODE 5552.15.540 LOT# 1715448 STER. 1800053; DELTA NEUTR.LINER ØINT 36MM #L CODE 5885.51.260 LOT# 1801318 STER. 1800063. DURING REVISION SURGERY THE FEMORAL HEAD AND THE LINER HAVE BEEN REPLACED AFTER A CLEAN OUT. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845638 FEM. MODULAR HEAD - L Ø36MM FEM. MODULAR HEAD - L Ø36MM (LPH-JDI-KWY-KWZ) LPH LIMACORPORATE SPA 5010.09.363 1707859

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention