BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CTA HUMERAL HEAD Ø46 MM

    MDR report key: 8397955 · Received March 7, 2019

    Report

    Report Number
    3008021110-2019-00022
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    February 13, 2019
    Report Date
    June 20, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    HSD
    PMA / PMN Number
    K110847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR ANALYSIS: BY CHECKING THE STERILIZATION CHARTS OF THE LOTS OF ALL THE COMPONENTS EXPLANTED ON (B)(6) 2019, NO ANOMALY WAS FOUND, THUS WE CAN STATE THAT THESE COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: EXPLANTS NOT AVAILABLE TO BE RETURNED TO LIMA CORPORATE. DUE TO HOSPITAL POLICIES ANY EXPLANTED ITEMS FROM PATIENTS ARE NOT DECONTAMINATED AND/OR RETURNED TO MANUFACTURER. XRAYS ANALYSIS: WE RECEIVED PRE-REVISION XRAYS AND SENT TO OUR MEDICAL CONSULTANT FOR A CLINICAL OPINION. BY XRAYS ANALYSIS, HE CONFIRMED THE PRESENCE OF INFECTION. HE STATED "I AM SUSPICIOUS THAT THERE IS DISTAL ENDOSTEAL CHANGE CONSISTENT WITH INFECTION AROUND THE HUMERAL STEM. [..] LEAVING THE STEM IN SITU IS NOT GOOD PRACTICE AND WHILE IT WILL BE DIFFICULT UNDER IDEAL CONDITIONS (IE NO RETAINED PROSTHESIS) IT WILL BE IMPOSSIBLE TO ERADICATE THE INFECTION WITH THE STEM RETAINED". BASED ON THE MULTIPLE MEDICAL OPINIONS WE RECEIVED ABOUT THE CLINICAL HISTORY OF THIS PATIENT PREVIOUSLY REPORTED AND CONSIDERING THE ANALYSIS OF THE DHRS OF THE LOTS INVOLVED, WE CAN CONCLUDE THAT MULTIPLE SURGERIES COULD HAVE STRONGLY CONTRIBUTED TO YET ANOTHER INFECTION FOR THIS PATIENT. IN CONCLUSION, THE EVENT IS NOT PRODUCT RELATED AND IS MORE LIKELY DUE TO MULTIPLE SURGERIES AND TO PATIENT FACTORS. PMS DATA: ACCORDING TO OUR PMS DATA, SMR REVERSE REVISION RATE DUE TO INFECTION IS 0.056%. NONE OF THE CASES WE COULD INVESTIGATE WERE CLASSIFIED AS PRODUCT RELATED. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2019. REMOVAL OF ALL THE COMPONENTS, WITH THE EXCEPTION OF THE STEM BECAUSE IT WAS WELL FIXED. ANTIBIOTICS TREATMENT. THE EXPLANTED COMPONENTS WERE: CTA HEAD 1323.09.460 LOT# 1404947 STER. 1400138 ADAPTOR 36MM FOR REVERSE BODY 1352.15.200 LOT# 1800755 STER. 1800162 ACCORDING TO THE INFORMATION RECEIVED THE PATIENT HAD A COMPLICATE HISTORY OF SHOULDER INSTABILITY AND WE CAN SUMMARIZE THE EVENTS AS FOLLOWING: - 1ST SURGERY WAS PERFORMED ON (B)(6) 2018; THIS SURGERY WAS NOT A PRIMARY TSR, SINCE PATIENT HAD A PREVIOUS FAILED ARTHROPLASTY (COMPETITOR IMPLANT). - 2ND SURGERY WAS PERFORMED ON (B)(6) 2018 (EVENT ASSOCIATED TO LIMA CORPORATE REF. 247/18, NOT REPORTED TO FDA BECAUSE THE INVOLVED PRODUCTS WERE NOT MARKED IN USA): REVISION SURGERY DUE TO SHOULDER INSTABILITY. - 3RD SURGERY WAS PERFORMED ON (B)(6) 2018 (EVENT ASSOCIATED TO LIMA CORPORATE REF. 328/18, NOT REPORTED TO FDA BECAUSE THE INVOLVED PRODUCTS WERE NOT MARKED IN USA): REVISION SURGERY DUE TO INSTABILITY. - OPEN REDUCTION PERFORMED ON (B)(6) 2018 AND ON (B)(6) 2018. - 4TH SURGERY WAS PERFORMED ON 29/09/2018 (EVENT ASSOCIATED TO LIMA CORPORATE REF. 332/18, NOT REPORTED TO FDA BECAUSE THE INVOLVED PRODUCTS WERE NOT MARKED IN USA): REVISION SURGERY DUE TO SHOULDER INSTABILITY AND DISLOCATION. - 5TH SURGERY WAS PERFORMED ON (B)(6)/2018 (EVENT ASSOCIATED TO LIMA CORPORATE REF. 358/18, NOT REPORTED TO FDA BECAUSE THE INVOLVED PRODUCTS WERE NOT MARKED IN USA) REVISION SURGERY DUE TO DISLOCATION. - 6TH SURGERY WAS PERFORMED ON (B)(6) 2018 (EVENT ASSOCIATED TO LIMA CORPORATE REF. 04/19, MFR 3008021110-2019-00002): REVISION SURGERY DUE TO INFECTION AND DISLOCATION 4 DAYS AFTER MOBILIZING THE SHOULDER WITHOUT THE SLING. - 7TH SURGERY WAS PERFORMED ON (B)(6) 2019 (OBJECT OF THE CURRENT REPORT, LIMA CORPORATE REF. 055/19): REMOVAL OF CTA HEAD FOR INFECTION. REP COVERED COMMENTED THAT REVISION STEM WAS WELL FIXED AND SO SURGEON DID NOT REMOVE THE STEM. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE LOT#S OF ALL THE COMPONENTS EXPLANTED ON (B)(6) 2019, NO ANOMALY WAS FOUND, THUS WE CAN STATE THAT THESE COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL REPORT AFTER FINAL INVESTIGATION.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2019. REMOVAL OF ALL THE COMPONENTS, EXCEPT THE STEM WHICH WAS WELL FIXED, AND IMPLEMENTATION OF ANTIBIOTICS TREATMENT. THE EXPLANTED COMPONENTS WERE: CTA HEAD 1323.09.460 LOT# 1404947 STER. 1400138; ADAPTOR 36MM FOR REVERSE BODY 1352.15.200 LOT# 1800755 STER. 1800162; ACCORDING TO THE INFORMATION RECEIVED THE PATIENT HAD A HISTORY OF SHOULDER INSTABILITY AND WE CAN SUMMARIZE THE EVENTS AS FOLLOWING: 1ST SURGERY WAS PERFORMED ON (B)(6) 2018; THIS SURGERY WAS NOT A PRIMARY TSR, SINCE PATIENT HAD A PREVIOUS FAILED ARTHROPLASTY (COMPETITOR IMPLANT). 2ND SURGERY WAS PERFORMED ON (B)(6) 2018 (LIMACORPORATE REF. (B)(4), NOT REPORTED TO FDA BECAUSE INVOLVED PRODUCTS WERE NOT MARKED IN US): REVISION SURGERY DUE TO SHOULDER INSTABILITY. 3RD SURGERY WAS PERFORMED ON (B)(6) 2018 (LIMACORPORATE REF. (B)(4), NOT REPORTED TO FDA BECAUSE INVOLVED PRODUCTS WERE NOT MARKED IN US): REVISION SURGERY DUE TO INSTABILITY. OPEN REDUCTION PERFORMED ON (B)(6) AND (B)(6) 2018. 4TH SURGERY WAS PERFORMED ON (B)(6) 2018 (LIMACORPORATE REF. (B)(4), NOT REPORTED TO FDA BECAUSE INVOLVED PRODUCTS WERE NOT MARKED IN US): REVISION SURGERY DUE TO SHOULDER INSTABILITY AND DISLOCATION. 5TH SURGERY WAS PERFORMED ON (B)(6) 2018 (LIMACORPORATE REF. (B)(4), NOT REPORTED TO FDA BECAUSE INVOLVED PRODUCTS WERE NOT MARKED IN US): REVISION SURGERY DUE TO DISLOCATION. 6TH SURGERY WAS PERFORMED ON (B)(6) 2018 (LIMACORPORATE REF. (B)(4), MFR 3008021110-2019-00002): REVISION SURGERY DUE TO INFECTION AND DISLOCATION 4 DAYS AFTER MOBILIZING THE SHOULDER WITHOUT THE SLING. 7TH SURGERY WAS PERFORMED ON (B)(6) 2019 (SUBJECT OF THIS REPORT, LIMACORPORATE REF. (B)(4)): REMOVAL OF CTA HEAD FOR INFECTION. REP COVERED COMMENTED THAT REVISION STEM WAS WELL FIXED AND SURGEON DID NOT WANT TO REMOVE THE STEM. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194298 SMR CTA HUMERAL HEAD Ø46 MM SMR CTA HUMERAL HEAD Ø46 MM (HSD-KWS ) HSD LIMACORPORATE SPA 1323.09.460 1404947

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention