BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 36MM HUM LINER +0

    MDR report key: 21120505 · Received January 9, 2025

    Report

    Report Number
    1038671-2025-00186
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    November 30, 2023
    Report Date
    July 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862086617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 300-30-06 - EQUINOXE PRESERVE STEM 6MM; (B)(6). 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED; (B)(6). 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; (B)(6). 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; (B)(6). 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; (B)(6). 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; (B)(6). 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; (B)(6). 320-31-36 - GLENOSPHERE, 36MM; (B)(6). 320-35-01 - SMALL GLENOID PLATE; (B)(6). 320-15-05 - EQ REV LOCKING SCREW; (B)(6). 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; (B)(6).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F. THE REVISION REPORTED MAY BE THE RESULT OF THE HUMERAL LINER WEAR AND INFECTION AS REPORTED. HOWEVER, THE SERIES OF EVENTS AND CONTRIBUTING FACTORS TO EACH CANNOT BE CONFIRMED AND ANY POTENTIAL CONTRIBUTIONS FROM USER OR PATIENT-RELATED CONTRIBUTING FACTORS TO THE EVENT CANNOT BE EVALUATED AS NO RADIOGRAPH, IMAGES, OR CLINICAL INFORMATION WAS PROVIDED. THE REASON FOR THE INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. A REVIEW OF THE STERILE CERTIFICATES WAS PERFORMED FOR ALL COMPONENTS. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. 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

    MEDWATCH 330-27000002025-01 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5 - USER FACILITY REPORT REFERENCE MOVED TO H10 FOR CORRECTION G2 - REPORT SOURCE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H10.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A MEDWATCH REPORT, "MEDWATCH (B)(4)", THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER REPLACEMENT AND RIGHT SHOULDER BICEPS TENODESIS PROCEDURE IN (B)(6) 2019 TO TREAT AN IRREPARABLE RIGHT ROTATOR CUFF TEAR AND BICEPS TENDINITIS. SUBSEQUENTLY, THE PATIENT REPORTED PAIN APPROXIMATELY 6 WEEKS POST-OPERATION THAT WAS RESOLVED WITH REST. APPROXIMATELY 2 YEARS POST-OPERATION, THE PATIENT AGAIN REPORTED PAIN; HOWEVER, NO EVIDENCE OF A MECHANICAL PROBLEM WAS OBSERVED. SUBSEQUENTLY, THE PATIENT REPORTED INTENSE PAIN THAT INTERFERED WITH SLEEP APPROXIMATELY 3 YEARS POST-OPERATION AND AN MRI WAS OBTAINED. THE MRI IDENTIFIED SUBACROMIAL BURSITIS, CONTAINING PARTICULATE DEBRIS AND CREATING AN INDOLENT PATTERN OF EROSION OF THE LATERAL MARGIN OF THE ACROMION PROCESS WITH A STRESS REACTION BUT NO FRACTURE LINE, AS WELL AS CHRONIC TEARS OF THE INFRASPINATUS, SUPRASPINATUS AND SUBSCAPULARIS TENDONS. FURTHER, CT IMAGING NOTED A SUBACUTE STRESS FRACTURE AT THE FAR LATERAL ASPECT OF THE ACROMION WITH AREAS OF BONY RESORPTION. ADJACENT DEGENERATIVE CHANGES OF THE AC JOINT AS WELL AS FLUID EXTENDING INTO THE UNDERLYING SUBACROMIAL SUBDELTOID BURSA. NO COMPLICATION OF THE HARDWARE ITSELF IN THE SETTING OF REVERSE TYPE TOTAL SHOULDER ARTHROPLASTY. IT WAS DISCUSSED WITH THE PATIENT THAT THE PARTICULATE DEBRIS THAT SHOWED ON THE MRI MAY BE A REACTION TO THE POLYETHYLENE. THE PATIENT UNDERWENT A REVISION PROCEDURE IN (B)(6) 2023, APPROXIMATELY 4 YEARS 4 MONTHS POST THE INITIAL PROCEDURE, OF THE GLENOSPHERE, HUMERAL TRAY, AND POLY LINER. INTRAOPERATIVELY NOTED WAS POLYETHYLENE WEAR ON THE INFERIOR ASPECT OF THE POLY, CONSISTENT WITH POSTERIOR INFERIOR NOTCHING, AS WELL AS AN EXUDATIVE MATERIAL ON THE SOFT TISSUE IN THE SUBACROMIAL SPACE. THE PATHOLOGY REPORTS FINAL DIAGNOSIS FOR THE SYNOVIUM RIGHT, INDICATED A TISSUE REACTION TO PARTICULATE IMPLANT MATERIAL ¿ FOR THE SOFT TISSUE: POLYETHELENE DEBRIS, MIXED SMALL AND LARGE PARTICULATE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2023. APPROXIMATELY 1 WEEK LATER, THE INTRA-OPERATIVE CULTURES OBTAINED DURING THE REVISION SHOWED BROTH ONLY CUTIBACTERIUM (PROPIONIBACTERIUM) ACNES. THE PATIENT WAS INSTRUCTED TO CONTINUING TO TAKE AUGMENTIN, ON WHICH HE HAD BEEN DISCHARGED FROM THE HOSPITAL. HE WAS SUBSEQUENTLY FOLLOWED BY INFECTIOUS DISEASE AND CONTINUED TREATMENT WITH ANTIBIOTICS FOR 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364757 145-DEG PE 36MM HUM LINER +0 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862086617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11