BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 LATERAL. FEMORAL STEM # 2

    MDR report key: 8964603 · Received September 5, 2019

    Report

    Report Number
    3008021110-2019-00094
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    August 20, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K170473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF DHR. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 22 PIECES PLACED ON THE MARKET WITH LOT# 1111725. FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME LOT#. EXPLANTS ANALYSIS. NO EXPLANTS AVAILABLE TO BE RETURNED FOR FURTHER ANALYSIS. PICTURES OF THE EXPLANTED COMPONENTS HAVE BEEN RECEIVED, CONFIRMING THE BREAKAGE OF THE FEMORAL NECK. X-RAYS ANALYSIS. A SINGLE X-RAY DATED 18TH OF AUGUST 2019 WAS RECEIVED FROM COMPLAINT SOURCE. BY OUR MEDICAL CONSULTANT JUDGEMENT, IT WAS IMPOSSIBLE TO DISTINGUISH ANY SPECIFIC MECHANISM HOW THE BREAKAGE OCCURRED. WE FURTHER INVESTIGATED ANY POSSIBLE LOT# ISSUE TO EXCLUDE SOME FAILURE DURING MANUFACTURING: NO EVIDENCES OF POSSIBLE SPECIFIC BATCH ISSUE, AS ON A TOTAL OF N.22 STEMS MANUFACTURED IN 2011 WITH THE LOT #1111725, N.19 STEMS HAVE BEEN IMPLANTED FROM FEBRUARY 2012 TO FEBRUARY 2016 WITHOUT RECEIVING FURTHER SIGNALINGS ON THIS LOT#. CONCLUSION: EVEN IF WE DID NOT HAVE THE CHANCE TO ANALYZE THE C2 BROKEN FEMORAL STEM INVOLVED, WE PERFORMED A CHECK OF THE MANUFACTURING CHARTS AND WE VERIFIED THAT NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 22 STEMS PLACED ON THE MARKET WITH LOT# 1111725 AND THAT NO FURTHER COMPLAINTS HAVE BEEN RECEIVED DESPITE A TOTAL OF 19 FEMORAL STEMS WITH THE SAME LOT# WERE IMPLANTED. WE WOULD ALSO LIKE TO GIVE EVIDENCE THAT INSTRUCTIONS FOR USE RELATED TO LIMA CEMENTLESS STEMS VALID AT THE TIME OF PREVIOUS SURGERY CLEARLY INDICATED OVERWEIGHT AMONG THE RISK FACTORS (BASED ON PATIENT DATA PROVIDED, BMI OF THE PATIENT WAS >28). WITH THE ONLY INFO AVAILABLE, IT IS NOT POSSIBLE TO ESTABLISH A CLEAR ROOT CAUSE OF THE EVENT. IMPORTANT INFO HAVE NOT BEEN RECEIVED (PATIENT'S LEVEL OF ACTIVITY, X-RAYS RELATED TO THE POST-OP PRIMARY SURGERY, EXPLANTS[?]) BUT BASED ON INVESTIGATION AND CONSIDERING MORE THAN 7 YEARS OF IMPLANT SURVIVORSHIP, THE CASE CAN BE CONSIDERED AS NOT PRODUCT RELATED. PMS DATA: MORE THAN 125700 C2 FEMORAL STEMS BELONGING TO THE WHOLE FAMILY (STANDARD + LATERALIZING STEMS) WERE SOLD WORLDWIDE SINCE 1997, AND WE ARE AWARE OF A TOTAL OF N.4 BREAKAGES OF C2 STEMS; THIS GIVES A VERY LOW BREAKAGE RATE ((B)(4)) RELATED TO THIS FAMILY OF DEVICES. AMONG THE COMPLAINTS RECEIVED, NONE WAS CLASSIFIED AS PRODUCT RELATED. MECHANICAL SAFETY OF THE C2 STEMS IS CONFIRMED BY BOTH THE ARE DEVICES VERY LONG CLINICAL HISTORY AND BY OUR GOOD POST-MARKET SURVEILLANCE DATA. NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS COMPLAINT WAS CLOSED ON MARCH 16TH 2020, HOWEVER THE MDR WAS NOT SUBMITTED AT THAT TIME DUE TO INTERNAL ERROR AND THUS IT IS SUBMITTED TODAY.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO THE BREAKAGE OF A C2 FEMORAL STEM WITH CODE 4511.15.040 LOT# 1111725. ACCORDING TO THE INFO RECEIVED, THE BREAKAGE OCCURRED WHILE THE PATIENT WAS WALKING DOWN A FLAT STREET. REVISION SURGERY TOOK PLACE ON (B)(6) 2019, PREVIOUS SURGEY ON (B)(6) 2012. PATIENT DATA: FEMALE, 71KG, 158CM. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#, NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4) PIECES PLACED ON THE MARKET WITH LOT# 1111725. FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY DUE TO THE BREAKAGE OF C2 STEM WITH CODE 4511.15.040 LOT# 1111725. ACCORDING TO THE INFO RECEIVED, THE BREAKAGE OCCURRED WHILE THE PATIENT WAS WALKING DOWN A FLAT STREET. REVISION SURGERY TOOK PLACE ON (B)(6) 2019, PREVIOUS SURGEY ON (B)(6) 2012. PATIENT DATA: FEMALE, (B)(6), 158CM. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760672 C2 LATERAL. FEMORAL STEM # 2 C2 LATERALIZING UNCEMENTED FEMORAL STEM (TI6AL4V) #2 LZO LIMACORPORATE S.P.A. 4511.15.040 1111725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention