BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER DOMELOCK , DOME, CENTRIC

    MDR report key: 10200601 · Received June 26, 2020

    Report

    Report Number
    0009613350-2020-00286
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    May 11, 2020
    Report Date
    November 4, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WHICH WAS RECEIVED ON SEP 15, 2020. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE OR 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 (SEE (B)(4)). SAMPLES WERE TAKEN DURING THIS PROCEDURE. AN LOW-GRADE INFECTION WAS DIAGNOSED AND A 2 STAGE REVISION OF THE IMPLANT WAS PERFORMED ON (B)(6), 2020. 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. 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, PRODUCT 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 THAT FOLLOWING ARTHROSCOPIC PROCEDURE (B)(6), 2020, A LOW-GRADE INFECTION WAS DIAGNOSED AND A 2 STAGE REVISION OF THE IMPLANT WAS PERFORMED ON (B)(6), 2020. 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 NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB) STERILIZATION CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE INFECTION. 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: 0009613350-2020-00274-3, 0009613350-2020-00272-3.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WHICH WAS RECEIVED ON JUL 20, 2020. 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).

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION DUE TO INFECTION.

    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 INFECTION. AN ARTHROSCOPIC INSPECTION WAS CONDUCTED TO IDENTIFY POSSIBLE INFECTION. THE RESULTS SHOWED LOW GRADE INFECTION. A 2-STAGE REVISION SURGERY HAS BEEN SCHEDULED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: MD HYBRID GLENOID BASE 4MM D BASE 4MM; ITEM#113954; LOT#945140. THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS CMP-(B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE EXPERIENCED INFECTION. A REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667367 ANATOMICAL SHOULDER DOMELOCK , DOME, CENTRIC PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2912819 00889024483309

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization