BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 9021487 · Received September 13, 2019

    Report

    Report Number
    3008021110-2019-00101
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    September 2, 2019
    Report Date
    April 14, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHR: WE CHECKED THE STER. CHARTS OF THE INVOLVED COMPONENTS, WITH THE FOLLOWING RESULTS: NO ANOMALY WAS FOUND ON A TOTAL OF 35 SMR CEMENTLESS FINNED STEMS MANUFACTURED WITH LOT #1811356, STER.1800275; NO ANOMALY WAS FOUND ON A TOTAL OF 63 SMR REVERSE HUMERAL BODIES MANUFACTURED WITH LOT #1816478, STER.1800369; NO ANOMALY WAS FOUND ON A TOTAL OF 79 SMR REVERSE HP LINERS MANUFACTURED WITH LOT#1808218, STER.1800228; NO ANOMALY WAS FOUND ON A TOTAL OF 78 SMR CONNECTORS MANUFACTURED WITH LOT #1814869 STER.1800325; NO ANOMALY WAS FOUND ON A TOTAL OF 44 SMR REVERSE HP GLENOSPHERES MANUFACTURED WITH LOT #1813147, STER.1800273; NO ANOMALY WAS FOUND ON A TOTAL OF 59 SMR GLENOID PEGS TT MANUFACTURED WITH LOT #1601271, STER.1600105; NO ANOMALY WAS FOUND ON A TOTAL OF 29 SMR GLENOID BASEPLATE MANUFACTURED WITH LOT #1809057, STER.1800245; NO ANOMALY WAS FOUND ON A TOTAL OF 70 BONE SCREWS MANUFACTURED WITH LOT #1815269, STER.1800336; NO ANOMALY WAS FOUND ON A TOTAL OF 152 BONE SCREWS MANUFACTURED WITH LOT #1815279, STER.1800343. THUS, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. XRAYS ANALYSIS: WE RECEIVED PRE-REVISION XRAYS TAKEN ON AUGUST 8TH, 2019 AND SENT THEM TO OUR MEDICAL CONSULTANT FOR A CLINICAL EVALUATION. HE COMMENTED AS PER FOLLOWING: "THE XRAY [[?]] SHOWS THE GLENOID COMPONENTS TO BE WELL POSITIONED AND NO EVIDENCE OF PROSTHESIS/BONE INTERFACE LYSIS. SIMILARLY THE HUMERAL STEM SHOWS NO OBVIOUS LYSIS BUT THE BODY SHOWS SOME BONEY CHANGES CONSISTENT WITH MINOR LYSIS. IN SUMMARY THE ARTHROPLASTY APPEARS WELL POSITIONED. THERE IS A KNOWN INFECTION WHICH IS NOT RELATED TO THE POSITIONING OF THE COMPONENTS. I HOPE THIS IS HELPFUL." ACCORDING TO THE MEDICAL EXPERT STATEMENT, THERE IS NO REASON TO BELIEVE THAT LIMA PROSTHESES WERE RESPONSIBLE FOR INFECTION. THEREFORE, STATING THAT: NO ANOMALY WAS FOUND IN THE STERILIZATION CHARTS OF THE ALL COMPONENTS INVOLVED. SWAB ANALYSIS SHOWED THE PRESENCE OF P.ACNES. PATIENT UNDERWENT SEVERAL SURGERIES (CURRENT SURGERY WAS THE FOURTH REVISION IN LESS THAN ONE YEAR FOR THIS PATIENT) AND MEDICAL EXPERT COMMENTED THAT XRAYS SHOW COMMON INFECTION WE CAN CONCLUDE THIS EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, SMR REVERSE REVISION RATE DUE TO INFECTION IS VERY LOW: (B)(4). NO SPECIFIC ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    FINAL REPORT RELATED TO LIMACORPORATE COMPLAINT #(B)(4). WITH THIS INCIDENT REPORT, WE WOULD LIKE TO (1) REVISE THE PRODUCT CODES AND LOTS PREVIOUSLY REPORTED AND (2) PROVIDE ROOT CAUSE ANALYSIS OF THE EVENT. EVENT DESCRIPTION: FIRST STAGE SHOULDER REVISION DUE TO INFECTION PERFORMED ON THE (B)(6) 2019. ACCORDING TO THE INFORMATION RECEIVED, GERM RESPONSIBLE FOR THE INFECTION IS P.ACNE. THIS PATIENT HAS HAD SEVERAL REVISION SURGERIES, SUMMARIZED AS PER FOLLOWING: PRIMARY SURGERY PERFORMED ON (B)(6) 2016; 1ST REVISION SURGERY PERFORMED ON THE (B)(6) 2018 (COMPLAINT #(B)(4)) DUE TO CUFF FAILURE); 2ND REVISION SURGERY PERFORMED ON THE (B)(6) 2018 (COMPLAINT #(B)(4) DUE TO INFECTION); 3RD REVISION SURGERY PERFORMED ON THE (B)(6) 2018 (THIS CASE WAS NOT REPORTED TO LIMACORPORATE, ROOT CAUSE OF EVENT IS STILL UNKNOWN). 4TH REVISION SURGERY PERFORMED ON THE (B)(6) 2019 (CURRENT REPORT, FIRST STAGE REVISION SURGERY). DURING THE LAST REVISION SURGERY, ALL THE FOLLOWING COMPONENTS - PREVIOSULY IMPLANTED - WERE REMOVED AND CEMENT SPACER ONLY WAS THEN IMPLANTED: SMR CEMENTLESS FINNED STEM COD. 1304.15.180 LOT #1811356 STER.1800275. SMR REVERSE HUMERAL BODY NOT MARKED IN USA. SMR REVERSE HP LINER MEDIUM NOT MARKED IN USA. SMR CONNECTOR SMALL STD COD. 1374.15.310 LOT #1814869 STER.1800325. SMR REVERSE HP GLENOSPH. 44 MM NOT MARKED IN USA. SMR GLENOID PEG TT S/STD/L #S COD. 1375.14.661 LOT #1601271 STER.1600105. SMR GLENOID BASEPLATE STANDARD COD. 1375.15.610 LOT #1809057 STER.1800245. BONE SCREW Ø6,5 H.20MM COD. 8420.15.010 LOT #1815269 STER.1800336. BONE SCREW Ø6,5 H.30MM COD. 8420.15.030 LOT #1815279 STER.1800343. NO OTHER INFO REPORTED BY THE COMPLAINT SOURCE. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    WE CHECKED THE STER. CHARTS OF THE INVOLVED COMPONENTS, WITH THE FOLLOWING RESULTS: NO PRE EXISTING ANOMALY WAS FOUND ON THE 45 STEMS PLACED ON THE MARKET WITH LOT 1602011 STER 1600081. NO PRE EXISTING ANOMALY WAS FOUND ON THE 60 HUMERAL HEADS PLACED ON THE MARKET WITH LOT 1807291 STER 1800194. NO PRE EXISTING ANOMALY WAS FOUND ON THE 65 ADAPTOR TAPERS PLACED ON THE MARKET WITH LOT 1713565 STER 1700395. NO PRE EXISTING ANOMALY WAS FOUND ON THE 50 HUMERAL BODIES PLACED ON THE MARKET WITH LOT 1800920 STER 1800066. THUS, WE CAN STATE THAT THESE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT OUR FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    FIRST STAGE SHOULDER REVISION DUE TO INFECTION PERFORMED ON (B)(6) 2019. PREVIOUS SURGERY WAS ALSO A REVISION SURGERY AND TOOK PLACE ON (B)(6) 2018. ACCORDING TO THE INFO RECEIVED, GERM RESPONSIBLE FOR THE INFECTION IS P.ACNE. DURING REVISION SURGERY ON (B)(6) THE PROSTHESIS WAS REMOVED AND CEMENT SPACER IMPLANTED. ACCORDING TO THE INFO RECEIVED UP TO NOW, THE FOLLOWING COMPONENTS HAVE BEEN EXPLANTED: SMR CEMENTED STEM Ø20 MM 1306.15.200 LOT 1602011 STER 1600081, SMR HUMERAL HEAD Ø52 MM 1322.09.520 LOT 1807291 STER 1800194, NEUTRAL ADAPTOR TAPER STANDARD 1330.15.270 LOT 1713565 STER 1700395, SMR TRAUMA HUM. BODY # SHORT 1350.15.030 LOT 1800920 STER 1800066, NO INFO ON THE GLENOID COMPONENTS. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823435 SMR CEMENTLESS FINNED STEM SMR CEMENTLESS FINNED STEM (HSD-KWT) HSD LIMACORPORATE SPA 1304.15.180 1811356

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention