BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CTA HUMERAL HEAD Ø50 MM

    MDR report key: 8054293 · Received November 9, 2018

    Report

    Report Number
    3008021110-2018-00101
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 29, 2018
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K110847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR CHECK: WE CHECKED THE STERILIZATION CHARTS OF THE FOLLOWING COMPONENTS: 1. CTA HEAD - CODE 1323.09.500, LOT# 1509278 STER. 1500247 . 2. ADAPTOR - CODE 1352.15.200, LOT# 1713524 STER. 1700373. 3. HUMERAL BODY CODE 1352.20.010 LOT# 1807969 STER. 1800194 (MODEL NOT MARKETED IN THE USA). 4. STEM CODE 1304.15.180 LOT#1715136 STER. 1800032. NO ANOMALY WAS FOUND, THUS, WE CAN STATE THAT THESE PRODUCTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS AND X-RAYS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE, WE ONLY RECEIVED SOME PHOTOS OF THE EXPLANTED COMPONENTS. X-RAYS DATED 06TH AUGUST 2018 HAVE BEEN PROVIDED TO US FROM THE COMPLAINT SOURCE AND SENT TO OUR MEDICAL CONSULTANT FOR A CLINICAL EVALUATION. HIS COMMENTS ARE REPORTED BELOW: "WHAT WE CAN SAY IS THAT THERE HAVE BEEN 6 AT LEAST OPERATIVE INTERVENTIONS ON THIS SHOULDER AND JUST THAT NUMBER ALONE RAISES THE POTENTIAL FOR INFECTION TO VERY HIGH. WE ALSO KNOW THAT THE LIKELIHOOD OF ELIMINATING THE INFECTION AND HAVING AN IMPROVED OUTCOME BY ANY FURTHER IMPLANTATION OTHER THAN THAT FOR TREATING INFECTION IS VERY LOW. I THINK THE ADVICE TO THE SURGEON SHOULD BE TO FORGOT THE POSSIBILITY OF FURTHER IMPLANTATION AND ACCEPT THE OUTCOME OF CONTROL OF INFECTION. IF THE PATIENT ACHIEVES REASONABLE CONTROL OF PAIN I WOULD STOP AT THAT POINT. THE POTENTIAL FOR FURTHER INFECTION OR DISLOCATION ASSOCIATED WITH FURTHER IMPLANTATION IS VERY HIGH". AT TODAY, NO OTHER REVISION SURGERIES INVOLVING THIS PATIENT WERE REPORTED TO LIMACORPORATE. CONCLUSION: ACCORDING TO OUR ANALYSIS, BASED ON THE DHRS CHECK (COMPONENTS PROPERLY STERILIZED) AND ON OUR MEDICAL CONSULTANT'S OPINION, WE CAN STATE THAT THIS CASE IS NOT PRODUCT RELATED. WE CANNOT GO BACK WITH CERTAINTY TO THE CAUSE FOR THE INFECTION, BUT WE CAN SPECULATE THAT THE SEVERAL SURGERIES PERFORMED ON THIS PATIENT'S SHOULDER COULD HAVE CONTRIBUTED TO THE EVENT. PMS DATA: ACCORDING TO OUR PMS DATA, THE REVISION RATE ASSOCIATED TO INFECTION CASES INVOLVING SMR ANATOMIC HEMI PROSTHESIS IS 0.08%. NONE OF THE COMPLAINTS WE COULD INVESTIGATE HAS BEEN CLASSIFIED AS PRODUCT-RELATED. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO DETECT ANY FURTHER SIMILAR ISSUE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY DUE TO SUSPECTED INFECTION PERFORMED ON (B)(6) 2018. PREVIOUS SURGERY PERFORMED ON (B)(6) 2018. SPECIMENS HAVE BEEN TAKEN DURING SURGERY AND THE INFECTION HAS BEEN CONFIRMED: GROWTH OF P.ACNES WAS FOUND (ACCORDING TO THE INFO RECEIVED, THIS PATIENT ALSO HAD ANOTHER PREVIOUS CASE OF INFECTION CAUSED BY P.ACNES, DETAILS UNKNOWN). ACCORDING TO THE INFO RECEIVED, THIS PATIENT ALREADY UNDERWENT SEVERAL REVISION SURGERIES IN 2018 (DUE TO DISLOCATION/INSTABILITY). PREVIOUS SURGICAL HISTORY CAN BE SUMMARIZED AS FOLLOWS: ON (B)(6) 2018 SMR REVERSE PROSTHESIS WAS IMPLANTED TO REPLACE A COMPETITOR'S ANATOMICAL TSR (NO INFO ABOUT PRIMARY SURGERY'S DATE); ON (B)(6) 2018 THE FIRST REVISION OF SMR REVERSE WAS PERFORMED DUE TO INSTABILITY (THIS EVENT HAS NEVER BEEN REPORTED TO LIMACORPORATE); ON (B)(6) 2018 THE SECOND SMR REVISION SURGERY DUE TO DISLOCATION TOOK PLACE (THIS IS OUR COMPLAINT #(B)(4)- NOT REPORTED TO FDA AS THE INVOLVED PRODUCT CODE IS NOT MARKETED IN USA). - ON (B)(6) 2018, ANOTHER SMR REVERSE REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION (THIS IS OUR COMPLAINT #239/18, IT WAS NOT REPORTED TO FDA BECAUSE CAUSE FOR REVISION WAS SOLELY PATIENT-RELATED) - ON (B)(6) 2018 PATIENT WAS REVISED DUE TO INFECTION (THIS SURGERY IS THE ONE ASSOCIATED TO THIS INCIDENT REPORT). DURING THIS REVISION SURGERY, CTA HEAD (CODE 1323.09.500, LOT# 1509278), ADAPTOR CODE 1352.15.200, LOT# 1713524) PREVIOUSLY IMPLANTED DURING REVISION SURGERY PERFORMED ON 23/07/2018 WERE EXPLANTED. ACCORDING TO THE INFO REPORTED, ALSO THE HUMERAL BODY (CODE 1352.20.010 LOT# 1807969) AND THE STEM (CODE 1305.15.180 LOT#1715136) HAVE BEEN EXPLANTED. THESE TWO COMPONENTS HAD BEEN IMPLANTED DURING PREVIOUS SURGERIES (STEM ON (B)(6) 2018, HUMERAL BODY ON (B)(6) 2018). EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    WE CHECKED THE STERILIZATION CHARTS OF THE 2 EXPLANTED COMPONENTS WHOSE CODE AND LOT ARE KNOWN (CTA HEAD - CODE 1323.09.500, LOT# 1509278 STER. 1500247 AND ADAPTOR - CODE 1352.15.200, LOT# 1713524 STER. 1700373), WITHOUT FINDING ANY ANOMALY. THUS, WE CAN STATE THAT THESE PRODUCTS HAD BEEN CORRECTLY 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

    REVISION SURGERY DUE TO SUSPECTED INFECTION PERFORMED ON (B)(6) 2018. PREVIOUS SURGERY PERFORMED ON (B)(6) 2018. ACCORDING TO THE INFO RECEIVED, THIS PATIENT ALREADY UNDERWENT SEVERAL REVISION SURGERIES IN 2018 (DUE TO DISLOCATION/INSTABILITY). IT WAS REPORTED TO US THAT DURING THIS REVISION SURGERY, CTA HEAD (CODE 1323.09.500, LOT# 1509278), ADAPTOR CODE 1352.15.200, LOT# 1713524), HUMERAL BODY (CODE AND LOT NOT KNOWN) AND STEM (CODE AND LOT NOT KNOWN) HAVE BEEN EXPLANTED. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896063 SMR CTA HUMERAL HEAD Ø50 MM CTA HUMERAL HEADS (COCRMO) DIA.50MM (HSD-KWS) HSD LIMACORPORATE S.P.A. 1323.09.500 1509278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention