BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REVERSE TOTAL SHOULDER HUMERUS

    MDR report key: 13898838 · Received March 25, 2022

    Report

    Report Number
    0009613350-2022-00185
    Event Type
    Injury
    Date Received
    March 25, 2022
    Report Date
    March 25, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    PHX
    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 (B)(6) TO EVALUATE THE FIVE-YEAR FOLLOW-UP OUTCOMES OF PRIMARY REVERSE SHOULDER REPLACEMENT, IN 159 PROCEDURES AND IMPLANTED IN 152 PATIENTS BETWEEN SEPTEMBER 2005 AND FEBRUARY 2012, WAS CARRIED OUT. THE STUDY REPORTED THAT 4 PATIENTS EXPERIENCED POST-OP HEMATOMA FORMATION WHICH EITHER SPONTANEOUSLY RESOLVED OR REQUIRED EVACUATION. 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 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 (B)(6) TO EVALUATE THE FIVE-YEAR FOLLOW-UP OUTCOMES OF PRIMARY REVERSE SHOULDER REPLACEMENT, IN 159 PROCEDURES AND IMPLANTED IN 152 PATIENTS BETWEEN SEPTEMBER 2005 AND FEBRUARY 2012, WAS CARRIED OUT. THE STUDY REPORTED THAT 4 PATIENTS EXPERIENCED POST-OP HEMATOMA FORMATION WHICH EITHER SPONTANEOUSLY RESOLVED OR REQUIRED EVACUATION. 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 AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. A HEMATOMA IS A MASS OF CLOTTED BLOOD THAT FORMS IN A TISSUE, ORGAN, OR BODY SPACE. A HEMATOMA CAN BE ASSOCIATED WITH PAIN, SWELLING, ECCHYMOSIS, SEROSANGUINOUS OR BLOODY DRAINAGE AFTER A RECENT SURGICAL PROCEDURE. THE DEVELOPMENT OF A POSTOPERATIVE HEMATOMA AFTER A PROCEDURE CAN BE CORRELATED WITH THE SURGICAL PROCEDURE AND PERIOPERATIVE ANTICOAGULATION THERAPY TO PREVENT DVT (PROPHYLAXIS). PATIENTS MAY BE AT INCREASED RISK FOR DEVELOPING HEMATOMAS IF THEY HAVE RECEIVED FRESH-FROZEN PLASMA, VITAMIN K, OR HORMONAL THERAPY AS WELL. MOST HEMATOMAS RESOLVE ON THEIR OWN, WITHOUT SURGICAL INTERVENTION, WHILE SOME OTHERS DO NOT. LARGER HEMATOMAS MAY NEED TO BE SURGICALLY EVACUATED IN ORDER TO RESOLVE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. 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 (B)(4) MANUFACTURING (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 4 PATIENTS EXPERIENCED POSTOP HEMATOMA FORMATION WHICH EITHER SPONTANEOUSLY RESOLVED OR REQUIRED EVACUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852008 UNKNOWN REVERSE TOTAL SHOULDER HUMERUS EXTREMITY PROSTHESIS PHX ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R