BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID PEG TT SMALL-R #L

    MDR report key: 9744876 · Received February 24, 2020

    Report

    Report Number
    3008021110-2020-00012
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    February 12, 2020
    Report Date
    March 5, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DHRS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS DETECTED ON ALL THE COMPONENTS EXPLANTED. THEREFORE, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET WITH THE INVOLVED LOT#/STER. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) GLENOID BASEPLATE SMALL-R WITH LOT #1810678 HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. PRE-REVISION SURGERY X- RAYS AND CT-SCAN (EXACT DATE UNKNOWN) WERE PROVIDED AND ANALYZED BY OUR MEDICAL CONSULTANT. HIS COMMENTS AS FOLLOWS: "I CAN SEE SOME PERIPROSTHETIC LYSIS AROUND THE METAPHYSEAL HUMERUS WHICH COULD BE CONSISTENT WITH INFECTION, BUT THE IMAGE IS NOT GOOD QUALITY. SIMILARLY, ON THE SINGLE CT IMAGE THERE IS A SUGGESTION OF LYSIS AROUND THE GLENOID PEG AGAIN CONSISTENT WITH INFECTION. THE POSITIONING AND CHOICE OF THE IMPLANTS ALL LOOKS SATISFACTORY AND I CANNOT SEE ANY EVIDENCE OF IMPINGEMENT. IN SUMMARY THERE IS NO SURGEON ERROR WITH THE IMPLANT POSITIONING. AT 2YEARS PLUS PERIPROSTHETIC INFECTION IS DEFINED AS HAEMATOGENOUS AND THE APPROPRIATE MANAGEMENT HAS BEEN UNDERTAKEN". IN CONCLUSION, WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE INFECTION REPORTED, HOWEVER, ACCORDING TO OUR ANALYSIS, THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT RELATED. PMS DATA: BASED ON OUR PMS DATA, WE CAN ESTIMATE A REVISION RATE OF SMR REVERSE DUE TO INFECTION OF (B)(4). NO SPECIFIC ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT. NOTE: THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    REVISION SURGERY OF SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2020 DUE TO INFECTION AND LOOSENING OF THE TT METAL BACK GLENOID. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2018. DURING REVISION SURGERY, THE FOLLOWING COMPONENTS WERE REMOVED: SMR GLENOID PEG TT SMALL-R #L 1375.14.653 - LOT# 1807961 STER.1800222. SMR CEMENTLESS FINNED STEM 1304.15.190 - LOT# 1809620 STER.1800227. SMR CONNECTOR SMALL R 1374.15.305 - LOT# 1812246 STER.1800266. SMR GLENOID BASEPLATE SMALL-R 1375.15.605 - LOT# 1810678 STER.1800249. CORTIC.BONE SCREW D.4,5 L.36MM 8431.15.036 - LOT# 1702122 STER.1700339. CORTIC.BONE SCREW D.4,5 L.46MM 8431.15.046 - LOT# 1511630 STER.1700070. WASHOUT OF THE JOINT WAS PERFORMED, AND CEMENT SPACER WAS IMPLANTED. EVENT OCCURRED IN NEW ZEALAND.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE INVOLVED LOT#S, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE ALL COMPONENTS EXPLANTED. THEREFORE, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET WITH THE INVOLVED LOT#/STER. WE WILL SUBMIT A FINAL INCIDENT REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2020 DUE TO INFECTION AND LOOSENING OF THE TT METAL BACK. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2018. DURING REVISION SURGERY, ALL THE FOLLOWING COMPONENTS WERE REMOVED: SMR GLENOID PEG TT SMALL-R #L 1375.14.653 - LOT# 1807961, STER.1800222. SMR CEMENTLESS FINNED STEM 1304.15.190 - LOT# 1809620 , STER.1800227. SMR CONNECTOR SMALL R 1374.15.305 - LOT# 1812246, STER.1800266. SMR GLENOID BASEPLATE SMALL-R 1375.15.605 - LOT# 1810678, STER.1800249. CORTIC.BONE SCREW D.4,5 L.36MM 8431.15.036 - LOT# 1702122, STER.1700339. CORTIC.BONE SCREW D.4,5 L.46MM 8431.15.046 - LOT# 1511630, STER.1700070. WASHOUT OF THE JOINT WAS PERFORMED AND CEMENT SPACER WAS IMPLANTED. ONCE INFECTION HAS CLEARED, PATIENT WILL BE CONVERTED TO REVERSE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209911 SMR GLENOID PEG TT SMALL-R #L SMR TT METAL BACK PEG (TI6AL4V) - S-R LONG KWS LIMACORPORATE S.P.A. 1375.14.653 1807961

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention