BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID BASEPLATE SMALL-R

    MDR report key: 19229772 · Received May 2, 2024

    Report

    Report Number
    3008021110-2024-00042
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 28, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2220467, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 30 DEVICES MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 25 OUT OF 30 GLENOID BASEPLATES WITH LOT #2220467 AND STER. 2200258 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS: EXPLANTED DEVICES WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY AND THREE CT-SCANS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE RECEIVED X-RAY - DATED 03/01/2024 - AND THREE CT-SCANS - DATED 07/09/2023 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "FIRST, THE IMPLANT CHOICE IS OKAY FOR A CYST IN THE GLENOID. BY CURETTING IT OUT AND +/- FILLING THE DEFECT AND COMPACTING IT PROPERLY, THE AXIOMA SEEM TO BE A GOOD OPTION. THIS IS SPECULATIVE PROVIDED THE CYST WAS NOT TOO BIG AND COMPROMISING THE GLENOID VAULT. THE PICTURES SHOW A CLEAR OSTEOLYTIC LINE AROUND THE PEG. THIS IS VERY SUSPICIOUS FOR INFECTION, PRIMARY INSTABILITY DUE TO UNDERSIZING OF THE PEG COULD BE ANOTHER REASON, WHICH WOULD BE THE SURGEON'S FAULT. THE MOST LIKELY SCENARIO IS INFECTION THEREFORE MAKING THIS A FATEFUL COURSE OF EVENTS. NO SIGNS FOR IMPLANT-RELATED FAILURE". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE DEVICES MANUFACTURED WITH LOT #2220467; · ACCORDING TO THE RECEIVED INFORMATION, THE BASEPLATE GOT LOOSEN DUE TO POSSIBLE INFECTION, AND SAMPLES HAVE BEEN TAKEN TO CONFIRM IT, HOWEVER NO INFORMATION IS AVAILABLE ON THE RESULTS; · ACCORDING TO THE MEDICAL CONSULTANT "THE PICTURES SHOW A CLEAR OSTEOLYTIC LINE AROUND THE PEG. THIS IS VERY SUSPICIOUS FOR INFECTION, PRIMARY INSTABILITY DUE TO UNDERSIZING OF THE PEG COULD BE ANOTHER REASON, WHICH WOULD BE THE SURGEON'S FAULT. THE MOST LIKELY SCENARIO IS INFECTION THEREFORE MAKING THIS A FATEFUL COURSE OF EVENTS. NO SIGNS FOR IMPLANT-RELATED FAILURE"; WE CANNOT DEFINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, STILL WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF TT METALBACKS - BELONGING TO THE FAMILY CODES 1375.15.605/610/620 - DUE TO LOOSENING IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2220467, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE 30 COMPONENTS MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THAT LOT #. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON APRIL 22ND, 2024, DUE TO LOOSENING OF THE SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2220467 - STER.2200258). THE BASEPLATE GOT LOOSEN DUE TO POSSIBLE INFECTION, AND SAMPLES HAVE BEEN TAKEN TO CONFIRM IT, HOWEVER NO INFORMATION IS AVAILABLE ON THE RESULTS. IT WAS REPORTED THAT THE PATIENT HAD NO IMPROVEMENT ON HER EXCITING PAIN OR RANGE OF MOTION FOLLOWING THE INITIAL SURGERY. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR REVERSE HP LATERALIZING LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT #2227136 - STER.2300014) - PRODUCT NOT SOLD IN THE US. · SMR SMALL-R CONNECTOR +2 (PRODUCT CODE 1374.15.312, LOT #2302506 - STER.2322247) · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2227904 - STER.2300005) - PRODUCT NOT SOLD IN THE US. · SMR GLENOID PEG TT SMALL-R #M (PRODUCT CODE 1375.14.652, LOT #2120777 - STER.2100345). · SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2220467 - STER.2200258). · 2 BONE SCREWS Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2301089 - STER.2300039). IT WAS REPORTED THAT UPON REMOVAL, THE TT PEG SHOWED NO BONE INTEGRATION. THE SURGEON PLANS ON COMPLETING THE SURGERY AT A FUTURE DATE WITH A CUSTOMIZED GLENOID (DATE NOT PLANNED YET). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. THE SURGEON OPERATING ON IT REPORTED THAT HE COULD HAVE POSSIBLY USED A LARGER PEG AS THERE WAS A BIG CYST IN THE VAULT OF THE GLENOID AT THAT TIME. PATIENT IS A FEMALE, 78 YEARS OLD. NO FURTHER CLINICAL INFORMATION IS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2024, DUE TO LOOSENING OF THE SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2220467 - STER.2200258). THE BASEPLATE GOT LOOSEN DUE TO POSSIBLE INFECTION, AND SAMPLES HAVE BEEN TAKEN TO CONFIRM IT. IT WAS REPORTED THAT THE PATIENT HAD NO IMPROVEMENT ON HER EXCITING PAIN OR RANGE OF MOTION FOLLOWING THE INITIAL SURGERY. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR REVERSER HP LATERALIZING LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT #2227136 - STER.2300014) - PRODUCT NOT SOLD IN THE US · SMR SMALL-R CONNECTOR +2 (PRODUCT CODE 1374.15.312, LOT #2302506 - STER.2322247) · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2227904 - STER.2300005) - PRODUCT NOT SOLD IN THE US · SMR GLENOID PEG TT SMALL-R #M (PRODUCT CODE 1375.14.652, LOT #2120777 - STER.2100345) · SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2220467 - STER.2200258) · 2 BONE SCREWS Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2301089 - STER.2300039). IT WAS REPORTED THAT UPON REMOVAL, THE TT PEG SHOWED NO BONE INTEGRATION. THE SURGEON PLANS ON COMPLETING THE SURGERY AT A FUTURE DATE WITH A CUSTOMIZED GLENOID. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2023. THE SURGEON OPERATING ON IT REPORTED THAT HE COULD HAVE POSSIBLY USED A LARGER PEG AS THERE WAS A BIG CYST IN THE VAULT OF THE GLENOID AT THAT TIME. PATIENT IS A FEMALE, 78 YEARS OLD. NO FURTHER CLINICAL INFORMATION IS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841735 SMR GLENOID BASEPLATE SMALL-R SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R KWS LIMACORPORATE S.P.A. 1375.15.605 2220467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other