BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 20639159 · Received November 8, 2024

    Report

    Report Number
    3008021110-2024-00098
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    September 27, 2024
    Report Date
    July 7, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    UDI-DI
    08033390272681
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THE INVOLVED LOT NUMBER. A FINAL REPORT WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CHECKING THE DHRS OF THE LOT NUMBER INVOLVED NO PRE-EXISTING ANOMALIES WERE HIGHLIGHTED ON THE PIECES MANUFACTURED WITH LOT NUMBER 22AT1YM. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES OUT OF (B)(4) MANUFACTURED WITH LOT. 22AT1YM - STER. (B)(4) HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. THE EXPLANT WAS RECEIVED AT LIMACOPORATE FOR FURTHER ANALYSIS AND FROM A VISUAL INSPECTION IT WAS NOTICED THAT THE METAL-BACK SHOWS LOCALIZED WEAR AND DAMAGE ON ONE SIDE. ADDITIONALLY, THE PRESENCE OF SMALL BURRS WAS OBSERVED ON THE SURFACE, WHICH ARE PRESUMED TO BE CAUSED BY SURGICAL INSTRUMENTATION USED DURING EXPLANTATION. THE X-RAY OF POST-OP ((B)(6) 2023), X- RAYS OF REVISION SURGERY AND OPERATIVE NOTES WERE PROVIDED BY THE COMPLAINT SOURCE. THE AVAILABLE INFORMATION AND X-RAYS WERE EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "POSTOP RADIOGRAPHS LOOK FINE, PERFECT RESTRORATION OF COR. THE OR REPORT IS UNREMARKABLE. THE MOST LIKELY MODE OF FAILURE IS ROTATOR CUFF FAILURE HERE. THERE IS NO SIGN OF IMPLANT RELATED FAILURE." IN CONCLUSION, CONSIDERING THAT THE CHECK OF DHRS REVEALED NO PRE-EXISTING ANOMALIES IN THE INVOLVED LOT NUMBER AND ACCORDING TO THE MEDICAL CONSULTANT THE MOST LIKELY CAUSE OF FAILURE IS PATIENT'S RELATED (ROTATOR CUFF FAILURE), WE MAY CLASSIFY THIS EVENT AS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF L1 LINERS - BELONGING TO THE FAMILY CODES (B)(6) - DUE TO WEAR IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL MDR REPORT.

    Description of Event or Problem · 0

    REVISION SHOULDER SURGERY ON (B)(6) 2024 DUE TO PAIN, LOSS OF RANGE OF MOTION OF SHOULDER AND LINER WEAR. PREVIOUS SURGERY PERFORMED ON (B)(6) 2023. THE PATIENT REPORTED SQUEAKING OF THE PROSTHESIS SINCE (B)(6) 2024 DURING CERTAIN MOVEMENTS, WHICH INTENSIFIED WITH INCREASED PAIN. THE FOLLOWING DEVICES WERE REPLACED DURING REVISION: · LINER F.MET.BACK GLEN.STANDARD (PRODUCT CODE: 1377.50.010, LOT. 22AT1YM - STER. (B)(4)) - SOLD IN US · SMR HUMERAL HEAD Ø48 MM (PRODUCT CODE: 1322.09.480 , LOT. 2120289 - STER. (B)(4)) - SOLD IN US · SMR UNCEMENT. GLENOID # STD (PRODUCT CODE: 1375.20.010, LOT. 2309307 - STER. (B)(4)) - NOT SOLD IN US · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE: 8420.15.040, LOT: 2322192 - STER. (B)(4)) - SOLD IN US · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE: 8420.15.040, LOT: 2322192 - STER. (B)(4)) - SOLD IN US PATIENT: MALE, 66 YEARS OLD, APPROXIMATE HEIGHT (M): 1.86, APPROXIMATE WEIGHT (KG): 87. EVENT OCCURRED IN GERMANY.

    Description of Event or Problem · 0

    REVISION SHOULDER SURGERY ON (B)(6) 2024 DUE TO PAIN, LOSS OF RANGE OF MOTION OF SHOULDER AND LINER WEAR. PREVIOUS SURGERY PERFORMED ON (B)(6) 2023. THE PATIENT REPORTED SQUEAKING OF THE PROSTHESIS SINCE (B)(6) 2024 DURING CERTAIN MOVEMENTS, WHICH INTENSIFIED WITH INCREASED PAIN. THE FOLLOWING DEVICES WERE REPLACED DURING REVISION: · LINER F.MET.BACK GLEN.STANDARD (PRODUCT CODE: 1377.50.010, LOT. 22AT1YM - STER. (B)(4)) - SOLD IN US. · SMR HUMERAL HEAD Ø48 MM (PRODUCT CODE: 1322.09.480 , LOT. 2120289 - STER. (B)(4)) - SOLD IN US. · SMR UNCEMENT. GLENOID # STD (PRODUCT CODE: 1375.20.010, LOT. 2309307 - STER. (B)(4)) - NOT SOLD IN US. · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE: 8420.15.040, LOT: 2322192 - STER. (B)(4)) - SOLD IN US. · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE: 8420.15.040, LOT: 2322192 - STER. (B)(4)) - SOLD IN US. PATIENT: MALE, 66 YEARS OLD, APPROXIMATE HEIGHT (M): 1.86, APPROXIMATE WEIGHT (KG): 87. EVENT OCCURRED IN GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881029 SMR SYSTEM SMR SYSTEM - METAL BACK LINER STANDARD KWS LIMACORPORATE S.P.A. 1377.50.010 22AT1YM 08033390272681

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention