BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID MEDIUM, ALPHA

    MDR report key: 14461520 · Received May 20, 2022

    Report

    Report Number
    1038671-2022-00596
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 1, 2022
    Report Date
    December 2, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862172686
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION (CONCOMITANT DEVICE(S): REPLICATOR PLATE. TORQUE SCREW. HUMERAL HEAD. GLENOID.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF INSUFFICIENT BONDS BETWEEN THE IMPLANTS AND THE BONES, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. THE EXTENT AND ROOT CAUSE OF THE LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 734, BEARINGS; 4756, APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS A2, A3, B5, D1, D2A, D2B, D4, D10, H1 AND H6 HAVE BEEN UPDATED ACCORDINGLY. CONCOMITANT DEVICE(S): 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S: (B)(6). 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT: (B)(6). 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA): (B)(6). 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS: (B)(6). 620-11-02 - ACCELERATE CONC. SYS REP BY 620-12-02: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: G1 CONTACT FIRST/LAST NAME, H6 COMPONENT CODE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-03071 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-1412-2024; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE FOLLOWING SECTIONS WERE UPDATED: G4- 510K NUMBER ADDED. H4. THE REVISION REPORTED WAS LIKELY THE RESULT OF INSUFFICIENT BONDS BETWEEN THE IMPLANTS AND THE BONES, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. THE EXTENT AND ROOT CAUSE OF THE LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 10 YEARS POST OP THE INITIAL TSA, THIS (B)(6) YEAR OLDFEMALE PATIENT WAS REVISED DUE ASEPTIC HUMERAL LOOSENING. PATIENT HAD PROGRESSIVE HUMERAL LUCENCY SINCE 2016 ON XRAY - NOW WITH GLENOID LOOSENING NOTED IN 2/2022. NO SPECIFIC MOI NOTED. SURGEON REMOVED THE STANDARD HUMERAL STEM, REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, GLENOID. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 10 YEARS POST OP THE INITIAL TSA, THE PATIENT EXPERIENCED PROGRESSIVE HUMERAL LUCENCY ON X-RAY - NOW WITH GLENOID LOOSENING NOTED. NO SPECIFIC MOI NOTED. THE PATIENT UNDERWENT REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519002 EQUINOXE CAGE GLENOID MEDIUM, ALPHA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. UNK 10885862172686
    708675 EQUINOXE CAGE GLENOID MEDIUM, ALPHA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. UNK 10885862172686

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| H SEE H10.| SEE H11.