BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOSPHERE Ø36MM SMALL-R

    MDR report key: 8644174 · Received May 27, 2019

    Report

    Report Number
    3008021110-2019-00061
    Event Type
    Injury
    Date Received
    May 27, 2019
    Date of Event
    May 16, 2019
    Report Date
    May 27, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR CHECK: BY CHECKING THE DHRS OF THE LOTS OF THE COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) METAL BACK GLENOIDS MANUFACTURED WITH LOT# 1208736 NOR ON THE (B)(4) GLENOSPHERE MANUFACTURED WITH LOT# 1210484. MANUFACTURING CHARTS OF THE SCREW (PACKAGED TOGETHER WITH THE GLENOSPHERE) WAS ALSO CHECKED AND FOUND WITH NO PRE-EXISTING ANOMALY. ADDITIONALLY, ACCORDING TO OUR RECORDS: ALL THE (B)(4) METAL BACK GLENOIDS WITH PRODUCT CODE 1375.20.005 AND LOT# 1208736 HAVE ALREADY BEEN IMPLANTED; AT LEAST (B)(4) (OUT OF (B)(4) MANUFACTURED) GLENOSPHERES WITH CODE 1376.09.025, LOT #1210484 HAVE ALREADY BEEN IMPLANTED WITHOUT RECEIVING ANY ADDITIONAL MEDICAL COMPLAINT. EXPLANTS ANALYSIS: EXPLANTS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR ANALYSIS. XRAYS ANALYSIS: WE RECEIVED SOME X-RAY IMAGES TAKEN IN (B)(6) 2019 (PRE-OP REVISION SURGERY). THE X-RAYS WERE EVALUATED BY OUR MEDICAL CONSULTANT. HIS COMMENTS: "AN IMMEDIATE POST OPERATIVE X-RAY WOULD BE REVEALING. I WOULD SPECULATE THAT THE GLENOSPHERE WOULD HAVE BEEN INSERTED WITH THE PROPER ROTATION AND HAS ROTATED SUBSEQUENTLY BECAUSE THERE WAS NOT PROPER ENGAGEMENT OF THE GLENOSPHERE INTO THE BASEPLATE. AGAIN IT IS A MORSE TAPER AND EVEN THOUGH IT IS A LOCKING SCREW IT IS THE INITIAL FIXATION INTO THE MORSE THAT IS CRITICAL FOR THE FIXATION. THERE NEEDS TO BE NO BONY OBSTRUCTION (I DO NOT SEE ANY EVIDENCE OF THAT) TO THE CORRECT PLACEMENT OF THE GLENOSPHERE, THEN BOTH IMPACTION TAPPING AND TIGHTENING AND REPEATING THAT PROCESS AT LEAST 3 TIMES (I DO MORE) WHICH ENSURES PROPER ENGAGEMENT AND FIXATION. AS WE PROBABLY DO NOT HAVE THE IMMEDIATE POST OPERATIVE VIEW IT IS NOT POSSIBLE TO STATE DEFINITIVELY THAT THERE IS EVIDENCE OF FAILURE AT THAT POINT I SUSPECT THAT WILL BE THE CASE. THE SECOND X-RAY SHOWS SUPERIOR MIGRATION OF THE CENTRAL PEG AND LYSIS AND MOVEMENT OF THE INFERIOR SCREW. IN BOTH X-RAYS THERE IS UPWARDS TILT OF THE GLENOID BASEPLATE (A MAJOR FACTOR IN LOOSENING) AND THERE IS SOME EVIDENCE OF IMPINGEMENT. ALTHOUGH WE DO NOT HAVE ABSOLUTE EVIDENCE (BECAUSE WE DO NOT HAVE THE XRAYS) THIS SORT OF FAILURE IS ALWAYS A FAILURE OF TECHNIQUE AND NOT PROSTHESIS FAILURE." UNFORTUNATELY, IMMEDIATE POST OP X-RAYS REFERRING TO SURGERY PERFORMED IN (B)(6) WERE NOT AVAILABLE TO BE PROVIDED TO US. IN ADDITION, THE EXPLANTS HAVE NOT BEEN RETURNED TO THE MANUFACTURER, THUS NO DEEPER ANALYSIS IS POSSIBLE AT THIS STAGE. ACCORDING TO THE INFO RECEIVED, THE CAUSE FOR REVISION SURGERY WAS RELATED TO LOOSENING OF THE METAL BACK (AND ROTATION OF THE GLENOSPHERE WITH RESPECT TO THE METAL BACK). IT HAS BEEN REPORTED THAT PATIENT'S BONE CONDITION WAS SUBOPTIMAL, THUS WE CAN SPECULATE THAT PATIENT'S FACTOR COULD HAVE CONTRIBUTED TO THE LOOSENING OF THE METAL BACK GLENOID. AS PER OUR MEDICAL CONSULTANT'S EVALUATION, ANOTHER CONTRIBUTING FACTOR TO THE EVENT WAS "A FAILURE OF IMPLANTING TECHNIQUE". SURGEON RESPONSIBLE FOR PREVIOUS SURGERY WAS DIFFERENT THAN THE SURGEON RESPONSIBLE FOR THE REVISION SURGERY. IN CONCLUSION, MOST PROBABLE CAUSE FOR THIS REVISION SURGERY IS A COMBINATION OF PATIENT'S POOR BONE QUALITY (CONTRIBUTING TO THE LOOSENING OF THE METAL BACK) AND SURGICAL FACTORS (POSSIBLE SUBOPTIMAL POSITIONING OF THE METAL BACK AND ASSEMBLY OF THE GLENOSPHERE DURING PREVIOUS SURGERY). EVENT NOT PRODUCT-RELATED. NOTE: THE PMS DATA ANALYSIS HAS BEEN FOCUSED ON THE COMPONENT IDENTIFIED AS SUSPECTED (METAL BACK GLENOID CODE 1375.20.005), WHICH IS NOT MARKETED IN USA. NO SPECIFIC ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FUTURE SIMILAR ISSUE.

    Description of Event or Problem · 0

    REVISION SURGERY OF A REVERSE SHOULDER PROSTHESIS PERFORMED ON (B)(6) 2019 DUE TO LOOSENING OF THE METAL BACK GLENOID - PRODUCT CODE 1375.20.005, LOT #1208736. IT HAS ALSO BEEN REPORTED THAT THE GLENOSPHERE (CODE 1376.09.025, LOT #1210484) "HAD ROTATED SIGNIFICANTLY EVEN THOUGH SCREW APPEARED TO BE ENGAGED". DURING THE REVISION SURGERY A CTA HUMERAL HEAD WAS IMPLANTED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2012. ACCORDING TO THE INFO RECEIVED, THE PATIENT FELT HIS SHOULDER WAS NEVER GREAT POST PREVIOUS SURGERY. PATIENT CLINICAL DATA: ARTHRITIC, 78 YEARS OLD, SUB-OPTIMAL BONE CONDITION. EVENT HAPPENED IN AUSTRALIA. NOTE: THIS CODE OF METAL BACK GLENOID (1375.20.005) IS NOT MARKETED IN USA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE LOT#S OF THE COMPONENTS INVOLVED, NO PREVIOUS ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED WITH THE LOT #1210484. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO GLENOID COMPONENTS LOOSENING PERFORMED ON (B)(6) 2019. THE UNCEMENTED GLENOID (NOT MARKED IN USA), SMR GLENOSPHERE Ø36MM SMALL-R (CODE 1376.09.025, LOT #1210484) AND REVERSE LINER HAVE BEEN REMOVED AND CTA HEAD IMPLANTED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2012. ACCORDING TO THE INFO REPORTED, THE PATIENT FELT SHOULDER WAS NEVER GREAT POST PREVIOUS SURGERY. GLENOSPHERE HAD ROTATED SIGNIFICANTLY EVEN THOUGH SCREW APPEARED TO BE ENGAGED. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437754 SMR GLENOSPHERE Ø36MM SMALL-R SMR GLENOSPHERE Ø36MM SMALL-R KWS LIMACORPORATE S.P.A. 1376.09.025 1210484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention