BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 9727099 · Received February 19, 2020

    Report

    Report Number
    0001825034-2020-00733
    Event Type
    Injury
    Date Received
    February 19, 2020
    Report Date
    July 22, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304475427
    PMA / PMN Number
    K080642
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; G4; G7; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE HUMERAL IMPLANT OF THE RIGHT SHOULDER ARTHROPLASTY IS LOOSE AND THE IMPLANT IS PROXIMALLY DISPLACED WITH DISLOCATION OF THE PROSTHETIC JOINT. THERE HAS BEEN APPARENT RESECTION OF A PORTION OF THE PROXIMAL HUMERUS RELATED TO TUMOR EXCISION AS DESCRIBED. LUCENCY IS NOTED ALONG THE HUMERAL IMPLANT MARGINS CONSISTENT WITH OSTEOLYSIS. OSSEOUS FRAGMENTS OF UNCERTAIN AGE ARE PRESENT INFERIOR TO THE GLENOSPHERE AND MEDIAL TO THE PROXIMAL HUMERUS. THE BONES ARE OSTEOPENIC. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00734. 0001825034-2020-00795. CUSTOMER IS INDICATED TO BE REVISED, BUT REVISION SURGERY DATE HAS YET TO BE SCHEDULED. CONCOMITANT MEDICAL PRODUCTS: PART #115330 LOT #524630. PART #115384 LOT #364490. PART #180509 LOT #211690. PART #180509 LOT #442880. PART #180510 LOT #918970. PART #180510 LOT #918970. PART #417200 LOT #0000633939. PART #402439 LOT #628120. PART #402439 LOT #632240. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. MMI REVIEW OF XRAYS HAD SIGNIFICANT FINDINGS OF LOOSENING, DISLOCATION, OSTEOPENIA, RADIOLUCENCY, AND OSTEOLYSIS. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED PATIENT UNDERWENT RIGHT REVERSE SHOULDER ARTHROPLASTY 9 YEARS AGO. SUBSEQUENTLY PATIENT IS INDICATED TO BE REVISED DUE TO DISLOCATION, LOOSENING, AND MIGRATION, BUT SURGERY HAS YET TO BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190749 ARCOM XL 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. NI 231090 00880304475427

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other SEE H10