BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER, HUMERAL STEM, CEMENTED, 12, 100 MM

    MDR report key: 10183268 · Received June 23, 2020

    Report

    Report Number
    0009613350-2020-00273
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    February 1, 2020
    Report Date
    November 3, 2020
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWS
    UDI-DI
    00889024483309
    PMA / PMN Number
    K142403
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020. ADDITIONAL'S: B5, H6. CORRECTIONS: B4, G4, G7, H10. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: H2, H6; CORRECTION: B4, B5, G4, G7, H10. EVENT DESCRIPTION: IT WAS REPORTED PATIENT INITIALLY WAS IMPLANTED WITH A RIGHT SIDE ANATOMICAL SHOULDER ON (B)(6) 2019. THE PATIENT REPORTED PAIN AND WAS SUSPECTED TO HAVE ATROPHY OF THE DELTOID. THE PATIENT UNDERWENT AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2020 AND WAS FOUND TO HAVE BURSITIS AND POSSIBLE MIGRATED ANCHOR. SAMPLES WERE TAKEN DURING THIS PROCEDURE REVIEW OF RECEIVED DATA: SURGICAL REPORT: MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IMPLANTATION SURGICAL REPORT: MEDICAL HISTORY OF ARTHRITIS, CLASSIC DELTOPECTORAL APPROACH. (THE TUBERCULUM MINUS OSTEOTOMY IS REDUCED BY 2 TRANSOSSEOUS FIBERWIRE WIRES AND 1 FIX ANCHOR REATTACHED, ADDITIONAL FIXATION BY MEANS OF 1 FOOTPRINT ANCHOR.) NO COMPLICATIONS NOTED DURING INITIAL PROCEDURE. ARTHROSCOPY SURGICAL REPORT: ARTHROSCOPIC EXPLORATION OF RIGHT SHOULDER, SEVERE BURSITIS REQUIRING BURSECTOMY, CUFF INTACT, IMPLANTS INTACT, HOWEVER ANCHOR (OF UNKNOWN DESIGN CONTROL) TO REPAIR SUBSCAPULARIS WHICH SEEMS TO HAVE MIGRATED. CULTURES TAKEN NO INDICATION OF INFECTION NOTED DURING PROCEDURE. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NCR(S): LOT: 2912819: 1 PART WAS SCRAPPED DUE TO INTERNAL HANDLING ERROR. NO NCR WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT WAS FOUND. STERILIZATION CERTIFICATE: THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICES CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATES OF THE AFFECTED LOT NUMBERS HAVE BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATIONS. CONCLUSION: IT WAS REPORTED PATIENT INITIALLY WAS IMPLANTED WITH A RIGHT SIDE ANATOMICAL SHOULDER ON (B)(6), 2019. THE PATIENT REPORTED PAIN AND WAS SUSPECTED TO HAVE ATROPHY OF THE DELTOID. THE PATIENT UNDERWENT AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2020 AND WAS FOUND TO HAVE BURSITIS AND POSSIBLE MIGRATED ANCHOR. SAMPLES WERE TAKEN DURING THIS PROCEDURE. PAIN CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE. THE DETECTED SEVERE BURSITIS AND POSSIBLY MIGRATED ANCHOR DURING ARTHROSCOPY MIGHT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PAIN. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED EVENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2020-00271-3 0009613350-2020-00285-3 NOTE: ANOTHER INCIDENT FOR THE SAME PATIENT HAS BEEN REPORTED WITH REPORT: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON SEP 15, 2020. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS(SURGICAL REPORTS) FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND EXPERIENCED PAIN WHICH WAS SUSPECTED TO BE ATROPHY OF THE DELTOID. THE PATIENT UNDERWENT AN ARTHROSCOPIC PROCEDURE ON MAY 11, 2020 AND WAS FOUND TO HAVE BURSITIS AND A MIGRATED ANCHOR.

    Description of Event or Problem · 0

    INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND EXPERIENCED PAIN WHICH WAS SUSPECTED TO BE ATROPHY OF THE DELTOID. THE PATIENT UNDERWENT AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2020 AND WAS FOUND TO HAVE BURSITIS AND A MIGRATED ANCHOR. PATIENT HAS UNDERGONE REVISION SURGERY AND ALL COMPONENTS HAVE BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MD HYBRID GLENOID BASE 4MM D BASE 4MM; REF#: (B)(4); LOT#: 945140. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON RIGHT SIDE AND EXPERIENCED PAIN 6 MONTHS POST SURGERY WHICH WAS TREATED BY ACROMIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649935 ANATOMICAL SHOULDER, HUMERAL STEM, CEMENTED, 12, 100 MM ANATOMICAL SHOULDER SYSTEM/ANATOMICAL SHOULDER DOMELOCK SYSTEM/ANATOMICAL SHOULD KWS ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2885749 00889024483309

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R