BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-6

    MDR report key: 6063026 · Received October 28, 2016

    Report

    Report Number
    0009613350-2016-01313
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    March 19, 2009
    Report Date
    October 6, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWS
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. THE PRODUCT HAS BEEN DISCARDED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL: IF FOLLOW-UP, WHAT TYPE? UPDATE: DATE RECEIVED BY MFR. TYPE OF REPORTS, EVALUATION CODES, ADDITIONAL MFR NARRATIVE NO TREND IDENTIFIED. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IN ARTICLE IT IS MENTIONED THAT A (B)(6) FEMALE PATIENT UNDERWENT REVISION SURGERY 9 MONTHS AFTER INDEX SURGERY DUE TO PERIPROSTHETIC STAPHYLOCOCCUS AUREUS INFECTION. THE ADDITIONAL INFORMATION RECEIVED REPORT IMPLANTATION DATE (B)(6) 2007, HAD PERIPROSTHETIC DEBRIDEMENT AND MOBILIZATION ON (B)(6) 2008 AND THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2009. THE SURGEON ASSURES THAT ALL COMPLICATIONS WERE NOT RELATED TO THE IMPLANTED PRODUCTS REVIEW OF RECEIVED DATA: - THE SURGICAL REPORT OF IMPLANTATION DATED (B)(6) 2007 WAS RECEIVED FOR REVIEW. NO CONSPICUOUSNESS. -THE SURGICAL NOTES OF DEBRIDEMENT AND MOBILIZATION DATED (B)(6) 2008 IS AVAILABLE. PATIENT WAS EXPERIENCING PAIN AND REDUCED RANGE OF MOTION, UNTIL THE LEFT SHOULDER HAS LOSS THE FUNCTIONALITY. IT IS REPORTED THAT IN (B)(6) 2007 THE PATIENT HAD A PUNCTION WHICH SHOWED NO BACTERIAL GROWING. THE SURGERY WAS PERFORMED TO FREE THE JOINT FROM SCAR TISSUE. INTRAOPERATIVE NO EVIDENCE OF INFECTION. -THE SURGICAL REPORT OF REVISION DATED (B)(6) 2009 WAS RECEIVED FOR REVIEW. THE NOTES STATES THAT THE PATIENT HAS PAIN AND THE REVISION IT'S PERFORMED TO CONVERT THE INVERSE SHOULDER BACK TO A HEMI-PROSTHESIS IN ORDER TO RELIEF PATIENT'S PAIN WITHOUT EXPECTING ANY FUNCTIONAL IMPROVEMENT. INTRAOPERATIVELY, SCAR TISSUE IS OBSERVED AND YELLOWISH-WHITISH MEMBRANES ARE FOUND BELOW THE INLAY AND THE HEAD. THE MEMBRANES AS WELL AS THE IMPLANTS ARE SENT FOR BACTERIOLOGICAL EVALUATION. NO OTHER CONSPICUOUSNESS. -ADDITIONALLY, THE NOTES OF A VISIT DATED (B)(6) 2009 ARE AVAILABLE. THE NOTES STATES THAT THE BACTERIOLOGICAL TESTS EVIDENCED OF DRUG RESISTANT BACTERIA. THE PATIENT NEEDED TO GET ANTIBIOTICS TO COMBATS THE INFECTION. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS THEY HAVE BEEN DISCARDED AT HOSPITAL AFTER THE REMOVAL. ROOT CAUSE ANALYSIS: THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOTS HAVE BEEN REVIEWED AND WERE FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE CAUSED THE INFECTION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THIS PRODUCT FAMILY. THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS D011500200 STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. THERE WAS NO EVIDENCE OF INFECTION UNTIL THE BACTERIAL TEST PERFORMED ON THE MATERIALS OF REVISION SURGERY ON (B)(6) 2009. ADDITIONALLY, THE SURGEON ASSURES THAT ALL COMPLICATIONS WERE NOT RELATED TO THE IMPLANTED PRODUCTS. CONCLUSION SUMMARY: IN ARTICLE IT IS MENTIONED THAT A (B)(6) FEMALE PATIENT UNDERWENT REVISION SURGERY 9 MONTHS AFTER INDEX SURGERY DUE TO PERIPROSTHETIC STAPHYLOCOCCUS AUREUS INFECTION. HOWEVER, THE RECEIVED SURGICAL NOTES ARE IN CONTRAST WITH THE EVENT REPORTED IN THE JOURNAL ARTICLE. THE SURGICAL NOTES STATE THAT THE PATIENT UNDERWENT A SURGERY AFTER 9 MONTHS (ON (B)(6) 2008), BUT THE IMPLANTS WERE LEFT IN SITU. 12 MONTH AFTER THIS SURGERY, ON (B)(6) 2009, THERE WAS A CONVERSION OF THE INVERSE SHOULDER BACK TO A HEMI-PROSTHESIS (WITH PRODUCT EXPLANTATION/EXCHANGE). THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOTS HAVE BEEN REVIEWED AND WERE FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE CAUSED THE INFECTION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THIS PRODUCT FAMILY. THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS D011500200 STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. THERE WAS NO EVIDENCE OF INFECTION UNTIL THE BACTERIAL TEST PERFORMED ON THE MATERIALS OF REVISION SURGERY ON (B)(6) 2009. ADDITIONALLY, THE SURGEON ASSURES THAT ALL COMPLICATIONS WERE NOT RELATED TO THE IMPLANTED PRODUCTS. AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED IN A JOURNAL ARTICLE. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-6 ON (B)(6) 2007 ON THE LEFT SIDE. THE SURGICAL TECHNIQUE WAS FOLLOWED. ON (B)(6) 2008 THE PATIENT UNDERWENT A PERIPROSTHETIC DEBRIDEMENT AND MOBILIZATION THE PARTS WERE LEFT IN SITU. THE PATIENT WAS REVISED ON (B)(6) 2009 DUE TO PERIPROSTHETIC INFECTION WITH STAPHYLOCOCCUS AUREUS. JOURNAL ARTICLE: "REVERSE TOTAL SHOULDER ARTHROPLASTY FOR FAILED OPEN REDUCTION AND INTERNAL FIXATION OF FRACTURES OF THE PROXIMAL HUMERUS", F. GRUBHOFER, K. WIESER, D.C. MEYER, S. CATANZARO, K. SCHܒHOLZ, C. GERBER. J SHOULDER ELBOW SURG. (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714709 ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-6 ANATOMICAL SHOULDER INVERSE/REVERSE KWS ZIMMER GMBH N/A 2317458

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R