BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, LEFT, 9X160MM

    MDR report key: 14370581 · Received May 12, 2022

    Report

    Report Number
    0009613350-2022-00276
    Event Type
    Injury
    Date Received
    May 12, 2022
    Report Date
    July 22, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505810
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X40MM ITEM#47-2486-040-40 LOT#3073745. BLUNT TIP SCREW, 4X46MM ITEM#47-2486-046-40 LOT#3073670. BLUNT TIP SCREW, 4X38MM ITEM#47-2486-038-40 LOT#3073751. CORTICAL BONE SCREW, 4X26MM REF: 47-2486-126-40; LOT: 3073754. CORTICAL BONE SCREW, 4X26MM REF: 47-2486-126-40; LOT: 3078185. REPORT SOURCE: FOREIGN - (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 - 00278, 0009613350 - 2022 - 00279, 0009613350 - 2022 - 00280. INVESTIGATION RESULTS ARE AVAILABLE. DEVICE WAS NOT RETURNED FOR ANALYSIS. INVESTIGATION AND CONCLUSION. EVENT DESCRIPTION: IT WAS REPORTED THAT: HUMERAL NAIL SURGERY ON 20.12.2021, X-RAY IMAGES (BEFORE/AFTER). 3.5 MONTHS AFTER SURGERY - PATIENT HAS LEFT SHOULDER PAIN. AFTER X-RAY CHECK, PROXIMAL SCREW MIGRATED. CORELOCK WAS PROPERLY LOCKED. OP TECHNIQUE WAS FOLLOWED. INTERVENTIONS TO CORELOCK WERE RETRAINED AGAIN IN JAN. 2022. THE PROXIMAL SCREW WAS REMOVED. HARM: S3 - INSTABILITY, MODERATE HAZARDOUS SITUATION: IMPLANT DETERIORATES, BREAKS OR LOSES FUNCTION POSTOPERATIVELY. REVIEW OF RECEIVED DATA: NO MEDICAL REPORTS AVAILABLE. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: THERE IS A X-RAY PICTURE AVAILABLE FOR INVESTIGATION. THE PICTURE SHOWS TWO DIFFERENT POSITIONED VIEWS - THERE IS A SLIGHT DISPLACEMENT OF THE IMPLANT POSITION. 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 PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE SAP EXPLAINS THAT THE LOCKING OF THE CORELOCK IS DONE USING THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. TURN SLOWLY CLOCKWISE TO TIGHTEN AND ENGAGE THE CORELOCK MECHANISM UNTIL A CLICK IS FELT FROM THE TORQUE LIMITING HANDLE. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION WITH NO NCR WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT WAS FOUND. CONCLUSION: IT WAS REPORTED THAT: HUMERAL NAIL SURGERY ON (B)(6) 2021, X-RAY IMAGES (BEFORE/AFTER). 3.5 MONTHS AFTER SURGERY - PATIENT HAS LEFT SHOULDER PAIN. AFTER X-RAY CHECK, PROXIMAL SCREW MIGRATED. CORELOCK WAS PROPERLY LOCKED. OP TECHNIQUE WAS FOLLOWED. INTERVENTIONS TO CORELOCK WERE RETRAINED AGAIN IN (B)(6) 2022. THE PROXIMAL SCREW WAS REMOVED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE RECEIVED X-RAYS CONFIRM THE REPORTED EVENT, NAMELY THAT THE MOST PROXIMAL SCREW HAS MIGRATED. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT FURTHER POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. A DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM AS A POTENTIAL CONTRIBUTING FACTOR AS WELL. HOWEVER, FURTHER BIOMECHANICAL TESTING WAS CARRIED OUT AND AS THE PRODUCT PERFORMANCE IS IN AN ACCEPTABLE RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES, NO DESIGN CHANGES WERE CONDUCTED. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H10 INVESTIGATION RESULTS: - THE INVOLVED BLUNT TIP SCREW WAS RETURNED FOR INVESTIGATION. THE VISUAL EXAMINATION OF THE RETURNED SCREW SHOWS SIGNS OF WEAR AROUND THE AREA OF THE HEXAGON SOCKET. ADDITIONALLY, MINOR POLISHED THREAD FLANKS CAN BE SEEN. THIS MOST LIKELY OCCURRED DUE TO DIRECT CONTACT BETWEEN THE SCREW AND THE NAIL, WHICH MAY POINT TO SCREW MIGRATION. - ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. - THE RECEIVED X-RAYS CONFIRM THE REPORTED EVENT, NAMELY THAT THE MOST PROXIMAL SCREW HAS MIGRATED. - BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT FURTHER POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. - IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROXIMAL SCREW MIGRATION WAS CONFIRMED THROUGH X-RAY 3.5 MONTHS AFTER IMPLANTATION SURGERY. IT WAS ALSO REPORTED THAT PATIENT HAS SHOULDER PAIN AND THE PROXIMAL SCREW HAD TO BE REMOVED. NO FURTHER OUTCOME REPORTED. INVESTIGATION RESULTS ARE NOW AVAILABLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954950 PROXIMAL HUMERUS, LEFT, 9X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3067316 00889024505810

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Required Intervention| H D10, MEDICAL PRODUCT: SEE H10 NARRATIVE