BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANATOMICAL SHOULDER

    MDR report key: 5450298 · Received February 22, 2016

    Report

    Report Number
    9613350-2016-00262
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    February 4, 2016
    Report Date
    June 17, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER FDA¿S DIRECTIVE, MEDWATCH REPORT HAS BEEN RESUBMITTED FOR REMOVING THREE ZEROS IN THE PREFIX OF MFR NUMBER(0009613350-2016-00262-1). ALL THE INFORMATION CAPTURED AS PER 0009613350-2016-00262 - 1 INCLUDING G4(DATE RECEIVED BY MANUFACTURER) EXCEPT B4. UPDATE: B5, G4, G7, H10. ON MARCH 28, 2016, A RESPONSE OF THE AUTHOR OF THE JOURNAL ARTICLE WAS RECEIVED WHICH CONTAINS THE REASON FOR THE PERFORMED REVISION SURGERY "GLENOID NOTCHING, LOOSENING, CUFF FAILURE". THIS ADDITIONAL INFORMATION IS INCLUDED IN THE REPORT AT HAND. NO FURTHER INFORMATION WAS RECEIVED AND IS NOT SUSPECTED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED IN A MEDICAL JOURNAL ARTICLE THAT A PATIENT WAS IMPLANTED AN UNKNOWN ANATOMICAL SHOULDER COMPONENT ON AN UNKNOWN DATE AND UNDERWENT A REVISION SURGERY BETWEEN 2005 AND 2012 DUE TO GLENOID NOTCHING, LOOSENING, CUFF FAILURE.

    Additional Manufacturer Narrative · 1

    DHR REVIEW: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. TREND ANALYSIS: TREND ANALYSIS COULD NOT BE PERFORMED AS NO REFERENCE NUMBER WAS AVAILABLE. COMPATIBILITY CHECK: THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS NO PRODUCT INFORMATION WAS PROVIDED. REVIEW OF INCOMING INFORMATION: IT WAS REPORTED IN THE JOURNAL ARTICLE THAT A PATIENT RECEIVED A AS TOTAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE AND WAS REVISED DUE TO UNKNOWN REASONS. NO OTHER DOCUMENTS WERE PROVIDED. DEVICES ANALYSIS: DEVICES ANALYSIS COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION WAS RECEIVED. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT 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. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN DFMEA. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A MEDICAL JOURNAL ARTICLE THAT A PATIENT WAS IMPLANTED AN UNKNOWN ANATOMICAL SHOULDER COMPONENT ON AN UNKNOWN DATE AND UNDERWENT A REVISION SURGERY BETWEEN 2005 AND 2012 DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108445 UNKNOWN ANATOMICAL SHOULDER ANATOMICAL SHOULDER KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R