BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS TRIAL HUMERAL PE-INLAY 36-0

    MDR report key: 8518414 · Received April 16, 2019

    Report

    Report Number
    0009613350-2019-00224
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 22, 2019
    Report Date
    July 10, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWS
    UDI-DI
    00889024287778
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR-REVIEW: AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INSTRUMENT BREAKS, DEFORMS OR PROVIDES INADEQUATE FUNCTION EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A REVISION SURGERY THERE WAS AN EXCHANGE OF THE SHELL AND INLAY ON THE HUMERUS. THE ORIGINAL AS-SCHAFT WAS LEFT AND THE CUP WAS IMPACTED IN-SITU. THE TRIAL REPOSITION WAS DONE WITH THE TRIAL HUMERAL PE-INLAY. DURING THE REMOVAL OF THE TRIAL, THE FIXING SPRINGS BROKE. THERE WAS A SHORT SURGICAL DELAY OF 1 MINUTE. NO PIECES OF THE BROKEN SPRING WERE LEFT IN THE PATIENT. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS THE PRODUCT WAS DISPOSED. REVIEW OF PRODUCT DOCUMENTATION: - THIS DEVICE IS INTENDED FOR TREATMENT. - INSTRUCTION FOR USE (IFU): THE IFU MENTIONS UNDER SECTION WARNINGS THE FOLLOWING: DO NOT SUBJECT INSTRUMENTS TO HIGH LOADS AND/OR IMPACT AS BREAKAGE CAN OCCUR. THE FOLLOWING IS ALSO DESCRIBED: BEFORE USING AN INSTRUMENT PLACED ON THE MARKET BY ZIMMER, THE OPERATING SURGEON SHOULD STUDY CAREFULLY THE FOLLOWING RECOMMENDATIONS, WARNINGS AND INSTRUCTIONS, AS WELL AS THE AVAILABLE INSTRUMENT SPECIFIC INFORMATION (E.G., PRODUCT LITERATURE, SURGICAL TECHNIQUE). CONCLUSION SUMMARY: IT WAS REPORTED THAT DURING A REVISION SURGERY THERE WAS AN EXCHANGE OF THE SHELL AND INLAY ON THE HUMERUS. THE ORIGINAL AS-STEM WAS LEFT AND THE CUP WAS IMPACTED IN-SITU. THE TRIAL REPOSITION WAS DONE WITH THE TRIAL HUMERAL PE-INLAY. DURING THE REMOVAL OF THE TRIAL, THE FIXING SPRINGS BROKE. THERE WAS A SHORT SURGICAL DELAY OF 1 MINUTE. NO PIECES OF THE BROKEN SPRING WERE LEFT IN THE PATIENT. THE QUALITY RECORDS (DHR) COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT AVAILABLE. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS THE PRODUCT WAS DISPOSED. FURTHERMORE, NO PICTURES OF THE BROKEN TRIAL INSTRUMENT WAS RECEIVED, THEREFORE THE CONDITION OF THE INSTRUMENT IS UNKNOWN. THE APPLICABLE IFU MENTIONS THE FOLLOWING: "DO NOT SUBJECT INSTRUMENTS TO HIGH LOADS AND/OR IMPACT AS BREAKAGE CAN OCCUR". THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION THE COMPLAINT COULD NOT BE CONFIRMED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4). NOTE: (B)(4) IS LINKED TO THIS COMPLAINT.

    Description of Event or Problem · 0

    INVESTIGATON RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS CLEARED FOR U.S. DISTRIBUTION UNDER EXEMPT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, IT IS INDICATED BY THE COMPLAINANT THAT IS HAS BEEN DISCARDED; HOWEVER AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY THERE WAS AN EXCHANGE OF THE SHELL AND INLAY ON THE HUMERUS. THE ORIGINAL AS-SCHAFT WAS LEFT AND THE CUP WAS IMPACTED IN-SITU. THE TRIAL REPOSITION WAS DONE WITH THE TRIAL HUMERAL PE-INLAY. DURING THE REMOVAL OF THE TRIAL, THE FIXING SPRINGS BROKE. NO PIECES OF THE BROKEN SPRING WERE LEFT IN THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310380 AS TRIAL HUMERAL PE-INLAY 36-0 N/A KWS ZIMMER GMBH N/A UNK 00889024287778

    Patients

    Seq Age Sex Outcome Treatment
    1