BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø48 MM

    MDR report key: 19266726 · Received May 8, 2024

    Report

    Report Number
    3008021110-2024-00043
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    March 22, 2024
    Report Date
    July 10, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND OUT. A MDR FINAL REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND OUT. ACCORDING TO OUR RECORDS, AT LEAST 23 OUT OF 30 SMR HUMERAL HEADS WITH LOT 1802620 AND STERILIZATION (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. NEITHER EXPLANTED COMPONENTS NOR X-RAYS WERE AVAILABLE TO BE RETRIEVED AND ANALYZED. THEREFORE, BASED ON THE FEW INFORMATION AVAILABLE, WE ARE NOT ABLE TO PERFORM ANY FURTHER INVESTIGATION. HOWEVER, ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE PATIENT HAS HAD A LONG HISTORY OF REVISION SURGERIES, AND THE PATIENT ANATOMY IS SUSPECTED TO HAVE CONTRIBUTED TO THE EVENT REPORTED. THEREFORE, CONSIDERING THAT: NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT. BASED ON THE INFORMATION RECEIVED, THE PATIENT HAS HAD A LONG HISTORY OF REVISION SURGERIES, AND THE PATIENT ANATOMY IS SUSPECTED TO HAVE CONTRIBUTED TO THE EVENT REPORTED. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR RECORD, THE OCCURRENCE RATE OF REVISION SURGERIES OF SMR ANATOMIC PROSTHESES DUE TO DISLOCATION IS AROUND 0.13%. BASED ON THE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS IS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION, PAIN, AND DELTOID ATONY. THE FOLLOWING COMPONENTS HAVE BEEN EXPLANTED: SMR HUMERAL HEAD Ø48 MM (PART CODE 1322.09.480, LOT NUMBER 1802620, STERILIZATION 1800100) SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.272, LOT NUMBER 1813641, STERILIZATION 1800325) SMR TRAUMA HUM. BODY # MEDIUM (PART CODE 1350.15.010, LOT NUMBER 1804787, STERILIZATION 1800129) THE ABOVE-MENTIONED COMPONENTS HAVE BEEN REPLACED WITH THE CUSTOM MADE IMPLANT CMD 23-1173 AND THE FOLLOWING STANDARD DEVICES: CORTICAL BONE SCREW (PART CODE 8432.15.034, LOT NUMBER 2109255, STERILIZATION 2100206) CORTICAL BONE SCREW (PART CODE 8432.15.032, LOT NUMBER 2301076, STERILIZATION 2300029) CORTICAL BONE SCREW (PART CODE 8432.15.028, LOT NUMBER 2113669, STERILIZATION 2100238) SMR CONNECTOR + SCREW (PART CODE 1374.15.310, LOT NUMBER 2312074, STERILIZATION 2300138) SMR REVERSE HP GLENOSPHERE DIA. 44 MM (PART CODE 1374.50.440, LOT NUMBER 2313222, STERILIZATION 2300130) SMR REVERSE HUMERAL BODY (PART CODE 1352.15.005, LOT NUMBER 2311935, STERILIZATION 2300145) SMR REVERSE HP LINER (PART CODE 1362.09.010, LOT NUMBER 2105016, STERILIZATION 2100144). THE CLINICAL HISTORY OF THE PATIENT IS SUMMARIZED AS FOLLOWS: THE PATIENT HAD A SEVERE FRACTURE OF THE HUMERAL BONE IN 2018. PRIMARY SURGERY WITH LIMACORPORATE COMPONENTS PERFORMED ON (B)(6) 2022 (SMR REVERSE COMPONENTS IMPLANTED) FIRST REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO IMPLANT DISLOCATION (NEW SMR REVERSE COMPONENTS IMPLANTED). THIS REVISION SURGERY IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00111. ON (B)(6) 2022, THE PATIENT PRESENTED WITH PAIN AFTER POST OP EXERCISES. X-RAY SHOWED DISLOCATION AND SIGNS OF IMPLANT LOOSENING. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 (NEW SMR REVERSE COMPONENTS IMPLANTED). THIS REVISION SURGERY IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00110 ON (B)(6) 2022, DURING FOLLOW UP VISIT THE PATIENT PRESENTED WITH SHOULDER DISLOCATION AND PAIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 (SMR REVERSE HP GLENOSPHERE IMPLANTED, PART CODE 1374.50.440, FDA COMPASSIONATE USE U220598 / LIMA CASE 22-1376). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00139) THE PATIENT DISLOCATED SHORTLY FOLLOWING THE SURGERY AND AS OF (B)(6) 2023, A 44MM ECCENTRIC/CORRECTIVE SMR REVERSE HP GLENOSPHERE NEEDED TO BE PLACED (PART CODE 1374.50.444). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH THE SUPPLEMENT SUBMISSION FOR FDA COMPASSIONATE USE U220598 / LIMA CASE 22-1376. X-RAYS TAKEN ON (B)(6) 2023, SHOWED THE PROSTHESIS TO BE DISLOCATED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2023, AND THE SMR REVERSE HP GLENOSPHERE (PART CODE 1374.50.444) HAS BEEN REPLACED BY A HEMIARTHROPLASTY (ANATOMIC). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) , NOT REPORTED TO THE FDA (EVENT CAUSED BY PATIENT CONDITION). X-RAYS TAKEN ON (B)(6) 2023, SHOWED THAT THE HEMIARTHROPLASTY (ANATOMIC) IS DISLOCATED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2024, AND THE CUSTOM MADE COMPONENT CMD (B)(6) HAS BEEN IMPLANTED (HEREBY REPORTED). THE LAST REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO INFECTION OF THE CUSTOM MADE COMPONENT CMD (B)(6) . THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) . THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1964. EVENT HAPPENED IN THE UNITED STATES.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION, PAIN, AND DELTOID ATONY. THE FOLLOWING COMPONENTS HAVE BEEN EXPLANTED: SMR HUMERAL HEAD Ø48 MM (PART CODE 1322.09.480, LOT NUMBER 1802620, STERILIZATION (B)(4) . SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.272, LOT NUMBER 1813641, STERILIZATION (B)(4). SMR TRAUMA HUM. BODY # MEDIUM (PART CODE 1350.15.010, LOT NUMBER 1804787, STERILIZATION (B)(4). THE ABOVE-MENTIONED COMPONENTS HAVE BEEN REPLACED WITH THE CUSTOM MADE IMPLANT CMD 23-1173 AND THE FOLLOWING STANDARD DEVICES: CORTICAL BONE SCREW (PART CODE 8432.15.034, LOT NUMBER 2109255, STERILIZATION (B)(4) CORTICAL BONE SCREW (PART CODE 8432.15.032, LOT NUMBER 2301076, STERILIZATION (B)(4). CORTICAL BONE SCREW (PART CODE 8432.15.028, LOT NUMBER 2113669, STERILIZATION (B)(4). SMR CONNECTOR + SCREW (PART CODE 1374.15.310, LOT NUMBER 2312074, STERILIZATION (B)(4). SMR REVERSE HP GLENOSPHERE DIA. 44 MM (PART CODE 1374.50.440, LOT NUMBER 2313222, STERILIZATION (B)(4). SMR REVERSE HUMERAL BODY (PART CODE 1352.15.005, LOT NUMBER 2311935, STERILIZATION (B)(4).) SMR REVERSE HP LINER (PART CODE 1362.09.010, LOT NUMBER 2105016, STERILIZATION (B)(4). THE CLINICAL HISTORY OF THE PATIENT IS SUMMARIZED AS FOLLOWS: THE PATIENT HAD A SEVERE FRACTURE OF THE HUMERAL BONE IN 2018. PRIMARY SURGERY WITH LIMACORPORATE COMPONENTS PERFORMED ON (B)(6) 2022 (SMR REVERSE COMPONENTS IMPLANTED). FIRST REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO IMPLANT DISLOCATION (NEW SMR REVERSE COMPONENTS IMPLANTED). THIS REVISION SURGERY IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00111. ON (B)(6) 2022, THE PATIENT PRESENTED WITH PAIN AFTER POST OP EXERCISES. X-RAY SHOWED DISLOCATION AND SIGNS OF IMPLANT LOOSENING. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 (NEW SMR REVERSE COMPONENTS IMPLANTED). THIS REVISION SURGERY IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00110 ON (B)(6) 2022, DURING FOLLOW UP VISIT THE PATIENT PRESENTED WITH SHOULDER DISLOCATION AND PAIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 (SMR REVERSE HP GLENOSPHERE IMPLANTED, PART CODE 1374.50.440, FDA COMPASSIONATE USE (B)(4) / LIMA CASE (B)(4). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00139). THE PATIENT DISLOCATED SHORTLY FOLLOWING THE SURGERY AND AS OF (B)(6) 2023, A 44MM ECCENTRIC/CORRECTIVE SMR REVERSE HP GLENOSPHERE NEEDED TO BE PLACED (PART CODE 1374.50.444). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH THE SUPPLEMENT SUBMISSION FOR FDA COMPASSIONATE USE (B)(4) / LIMA CASE (B)(4). X-RAYS TAKEN ON (B)(6) 2023, SHOWED THE PROSTHESIS TO BE DISLOCATED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2023, AND THE SMR REVERSE HP GLENOSPHERE (PART CODE 1374.50.444) HAS BEEN REPLACED BY A HEMIARTHROPLASTY (ANATOMIC). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) , NOT REPORTED TO THE FDA (EVENT CAUSED BY PATIENT CONDITION). X-RAYS TAKEN ON (B)(6) 2023, SHOWED THAT THE HEMIARTHROPLASTY (ANATOMIC) IS DISLOCATED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2024, AND THE CUSTOM MADE COMPONENT CMD 23-1173 HAS BEEN IMPLANTED (HEREBY REPORTED). THE LAST REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO INFECTION OF THE CUSTOM MADE COMPONENT CMD 23-1173. THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1964. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758778 SMR HUMERAL HEAD Ø48 MM SMR SHOULDER SYSTEM - HUMERAL HEADS (COCRMO) DIA.48MM KWT LIMACORPORATE S.P.A. 1322.09.480 1802620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention