BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 20-1413 GLENOID IMPLANT

    MDR report key: 13730231 · Received March 11, 2022

    Report

    Report Number
    3008021110-2022-00014
    Event Type
    Injury
    Date Received
    March 11, 2022
    Report Date
    November 20, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WE WILL SEND A FINAL INVESTIGATION REPORT ONCE THE REVISION SURGERY WILL BE PERFORMED. A TOTAL OF 3 BONE SCREWS (DIFFERENT LOT NUMBERS*) WERE PREVIOUSLY IMPLANTED ON (B)(6) 2021. AT THE MOMENT WE DO NOT KNOW WHICH ONE BROKE. 2000418 ,2000423 ,AND 2000424. POSTOPERATIVE FOLLOW-UP REPORT FOR FDA COMPASSIONATE USE REQUEST U210072- DR. (B)(6), PATIENT P.B. WAS SENT TO FDA.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A TOTAL OF 3 BONE SCREWS WERE PREVIOUSLY IMPLANTED IN (B)(6) 2021. IT IS UNKNOWN WHICH ONE GOT BROKEN. CHECKING THE DHR OF THE 3 BONES SCREWS INVOLVED IN THIS COMPLAINT, NO ANOMALY WAS FOUND. THEREFORE, WE CAN CONCLUDE THAT THE PRODUCTS HAVE BEEN CORRECTLY MANUFACTURED BEFORE BEING PLACED ON THE MARKET. REGARDING THE CUSTOM-MADE IMPLANT INVOLVED IN THIS COMPLAINT, THE DHR HAS BEEN CHECKED, WITHOUT FINDING ANY ANOMALY RELATED TO THE EVENT. X-RAYS AND EXPLANT ANALYSIS: THE COMPONENTS ARE NOT AVAILABLE TO BE RETURNED. WE HAVE RECEIVED THE PRE-OPERATIVE AND THE POST-OPERATIVE X-RAYS, AND THEY WERE SENT TO THE MEDICAL EXPERT. ACCORDING TO HIS EVALUATION: "THERE IS SEPTIC OR ASEPTIC LOOSENING OF THE GLENOID IMPLANT";"THE SCREW BREAKAGE THEREFORE IS DUE TO THE DISEASE OF THE PATIENT". "THERE IS NO IMPLANT-RELATED PROBLEM." THEREFORE, CONSIDERING THAT: NO ANOMALY WAS FOUND BY CHECKING THE DHR OF THE 3 BONE SCREWS IMPLANTED. NO ANOMALY RELATED TO THE EVENT WAS FOUND BY CHECKING THE DHR OF THE CUSTOM-MADE GLENOID COMPONENT INVOLVED IN THIS EVENT. ACCORDING TO THE MEDICAL EXPERT'S EVALUATION, THE SCREW BREAKAGE WAS DUE TO THE PATIENT'S CONDITION (SEPTIC OR ASEPTIC LOOSENING), AND NO IMPLANT-RELATED PROBLEM OCCURRED. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. SINCE THE INTERNAL INVESTIGATION LED TO THE CONCLUSION THAT THE SUSPECTED DEVICE IS THE CUSTOM-MADE GLENOID, WE CHANGED THE SUSPECT MEDICAL DEVICE IN MDR FROM THE CORTICAL BONE SCREW TO THE CUSTOM-MADE GLENOID (SEE PART D. OF THIS REPORT). PMS DATA: THE EVENT REPORTED BY COMPLAINT SOURCE IS LOOSENING OF A CUSTOM-MADE GLENOID IMPLANT. NO REVISION RATE TO BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. NO CORRECTIVE ACTIONS ARE PLANNED FOR THIS CASE. LIMACORPORATE KEEPS MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE THIS IS THE FINAL MDR.

    Description of Event or Problem · 0

    BREAKAGE OF THE BONE SCREW OBSERVED ON X-RAYS. SURGEON WILL EVALUATE REVISION SURGERY AND A POSSIBLE CUSTOMIZED IMPLANT. ACCORDING TO THE COMPLAINT SOURCE, THERE IS A POSSIBILITY THAT THE GLENOID COMPONENT/SCREWS WILL BE REMOVED AND REPLACED WITH A THIRD-PARTY SPACER. PATIENT CLINICAL HISTORY: PATIENT IS A (B)(6) FEMALE WHO UNDERWENT SUCCESSFUL IMPLANTATION OF A PATIENT-MATCHED GLENOID COMPONENT UNDER LIMA CASE (B)(4) ON (B)(6) 2021; PATIENT WAS SEEN ON (B)(6) 2021 FOR THE FIRST POSTOPERATIVE VISIT. AT THAT TIME, IT WAS NOTED TO BE DOING WELL WITH NO POST-OPERATIVE ISSUES OR CONCERNS. X-RAYS TAKEN SHOWED POSSIBLE SUBTLE LUCENCY (MINOR SPACE) BETWEEN THE GLENOID COMPONENT AND THE ACROMION, HOWEVER, THE SURGEON DID NOT NOTE THIS TO BE OF ANY CONCERN; FOLLOW-UP X-RAYS TAKEN ON (B)(6) 2021 DEMONSTRATED THE COMPONENTS TO BE WITHIN NORMAL LIMITS WITH NO ISSUES; LAST X-RAY - EXACT DATE UNKNOWN - SHOWED A SCREW BREAKAGE (OBJECT OF THIS CASE).

    Description of Event or Problem · 0

    LOOSENING OF A CUSTOM-MADE IMPLANT AND BREAKAGE OF A BONE SCREW OBSERVED ON X-RAYS DURING A FOLLOW-UP. THE COMPONENTS INVOLVED ARE THE FOLLOWING: (B)(6) GLENOID IMPLANT (PRODUCT CODE 9618.14.01J, LOT NUMBER 2103303, STERILIZATION 2100061). CORTIC.BONE SCREW D.4,5 L.30MM (PRODUCT CODE 8431.15.030, LOT NUMBER 2000418, STERILIZATION 2000021). CORTIC.BONE SCREW D.4,5 L.38MM (PRODUCT CODE 8431.15.038, LOT NUMBER 2000423, STERILIZATION 2000021). CORTIC.BONE SCREW D.4,5 L.40MM (PRODUCT CODE 8431.15.040, LOT NUMBER 2000424, STERILIZATION 2000021). PATIENT CLINICAL HISTORY: PATIENT IS A 73 YEAR OLD FEMALE WHO UNDERWENT SUCCESSFUL IMPLANTATION OF A PATIENT-MATCHED GLENOID COMPONENT UNDER LIMA CASE (B)(4) ON (B)(6) 2021, REPORTED TO THE FDA BY POSTOPERATIVE FOLLOW-UP REPORT FOR FDA COMPASSIONATE USE REQUEST U210072; PATIENT WAS SEEN ON (B)(6) 2021 FOR THE FIRST POSTOPERATIVE VISIT. AT THAT TIME, IT WAS NOTED TO BE DOING WELL WITH NO POST-OPERATIVE ISSUES OR CONCERNS. X-RAYS TAKEN SHOWED POSSIBLE SUBTLE LUCENCY (MINOR SPACE) BETWEEN THE GLENOID COMPONENT AND THE ACROMION, HOWEVER, THE SURGEON DID NOT NOTE THIS TO BE OF ANY CONCERN; FOLLOW-UP X-RAYS TAKEN ON (B)(6) 2021 DEMONSTRATED THE COMPONENTS TO BE WITHIN NORMAL LIMITS WITH NO ISSUES; LAST X-RAY - EXACT DATE UNKNOWN - SHOWED A SCREW BREAKAGE (OBJECT OF THIS CASE) THE PATIENT UNDERWENT A SUBSEQUENT SURGERY WITH THE EXPLANT OF THE CUSTOM GLENOID COMPONENT (B)(4) AND A REVISION TO HEMIARTHROPLASTY PERFORMED ON (B)(6) 2022. EVENT HAPPENED IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361565 CMD 20-1413 GLENOID IMPLANT CMD 20-1413 GLENOID IMPLANT - CUSTOM MADE KWS LIMACORPORATE S.P.A. 9618.14.01J 2103303
    2879770 CMD 20-1413 GLENOID IMPLANT CMD 20-1413 GLENOID IMPLANT - CUSTOM MADE KWS LIMACORPORATE S.P.A. 9618.14.01J 2103303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other