BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER EXTREMITIES IMPL WIN GEN

    MDR report key: 13514664 · Received February 11, 2022

    Report

    Report Number
    0009613350-2022-00075
    Event Type
    Injury
    Date Received
    February 11, 2022
    Report Date
    March 23, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSD
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: IT WAS REPORTED IN A JOURNAL ARTICLE RETRIEVED FROM SHOULDER & ELBOW (2020) THAT A MULTICENTER PROSPECTIVE STUDY FROM SWITZERLAND TO EVALUATE THE FIVE-YEAR FOLLOW-UP OUTCOMES OF PRIMARY REVERSE SHOULDER REPLACEMENT, IN 159 PROCEDURES AND IMPLANTED IN 152 PATIENTS BETWEEN (B)(6) 2005 AND (B)(6) 2012, WAS CARRIED OUT. THE STUDY REPORTED THAT 1 PATIENT UNDERWENT PRIMARY RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2010 AND SUBSEQUENTLY UNDERWENT REVISION OF THE HUMERAL COMPONENT ON (B)(6) 2013 DUE TO GLENOID IMPLANT LOOSENING. REVIEW OF RECEIVED DATA: NO MEDICAL DOCUMENTATION (X-RAYS, SURGICAL REPORT, HOSPITAL NOTES) RELEVANT TO THE CASE HAS BEEN RECEIVED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. JOURNAL ARTICLE RETRIEVED FROM SHOULDER & ELBOW (2020), WHICH WAS REVIEWED BY WARSAW HEALTHCARE PROVIDER (HCP). 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 COULD NOT BE PERFORMED DUE TO MISSING PRODUCT IDENTIFICATION. DHR REVIEW: THE DHR REVIEW COULD NOT BE PERFORMED DUE TO MISSING PRODUCT IDENTIFICATION. CONCLUSION: IT WAS REPORTED IN A JOURNAL ARTICLE RETRIEVED FROM SHOULDER & ELBOW (2020) THAT A MULTICENTER PROSPECTIVE STUDY FROM SWITZERLAND TO EVALUATE THE FIVE-YEAR FOLLOW-UP OUTCOMES OF PRIMARY REVERSE SHOULDER REPLACEMENT, IN 159 PROCEDURES AND IMPLANTED IN 152 PATIENTS BETWEEN (B)(6) 2005 AND (B)(6) 2012, WAS CARRIED OUT. THE STUDY REPORTED THAT 1 PATIENT UNDERWENT PRIMARY RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2010 AND SUBSEQUENTLY UNDERWENT REVISION OF THE HUMERAL COMPONENT ON (B)(6) 2013 DUE TO GLENOID IMPLANT LOOSENING. BASED ON THE RECEIVED JOURNAL ARTICLE (SHOULDER & ELBOW) THE REPORTED EVENT CAN BE CONFIRMED. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICE(S) OR PHOTOS OF THE DEVICE(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) IS UNKNOWN. PATIENT FACTORS THAT MAY HAVE AFFECTED THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. DUE TO SIGNIFICANT LACK OF INFORMATION A DETAILED INVESTIGATION COULD NOT BE PERFORMED, NEVERTHELESS BASED ON THE GIVEN INFORMATION THERE IS NO INDICATION OF A NONCONFORMANCE OR COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS 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).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 (B)(4). PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A JOURNAL ARTICLE WAS RETRIEVED FROM SHOULDER & ELBOW (2020) THAT REPORTED A MULTICENTER PROSPECTIVE STUDY FROM (B)(6). THE PURPOSE OF THE STUDY WAS TO EVALUATE THE FIVE-YEAR FOLLOW-UP OUTCOMES OF PRIMARY REVERSE SHOULDER REPLACEMENT UTILIZING TWO DIFFERENT DESIGNS OF GLENOID BASEPLATES. THE STUDY REPORTED 1 PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION OF THE HUMERAL COMPONENT DUE TO GLENOID IMPLANT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050438 ANATOMICAL SHOULDER EXTREMITIES IMPL WIN GEN EXTREMITIES PROSTHESIS HSD ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R