BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 13MMX21.5CM 130 R

    MDR report key: 17569925 · Received August 18, 2023

    Report

    Report Number
    0009613350-2023-00464
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    July 19, 2023
    Report Date
    November 16, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024586086
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: Z NAIL CMF 10.5 X 100 LAG SCR; REF#47249910010; LOT#3079131. Z NAIL 5.0X27.5 CORT SCREW FA; REF#47248402750; LOT#65363164. Z NAIL 5.0X27.5 CORT SCREW FA; REF#47248402750; LOT#65441418. Z NAIL CMF NAIL CAP 5MM; REF# 47250000205; LOT#3081921. Z NAIL CMF 5.0X80 ANT SUP SCR; REF#47250108050; LOT#3083299. G2- JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00463.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6. INVESTIGATION FINDINGS: MALFUNCTION OBSERVED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. SURGICAL TECHNIQUE SAP: REVIEW SURGICAL TECHNIQUE: THE CORRECT IMPLANTATION AND INSERTION (TLS PLACEMENT AND SET SCREW LOCKING) IS DESCRIBED IN THE SURGICAL TECHNIQUE. PLEASE ALSO NOTE THE FOLLOWING SECTION REGARDING "SET SCREW LOCKING": AFTER THE TLS IS PLACED, THE PRE-ASSEMBLED SETSCREW IN THE NAIL MUST BE TIGHTENED WITH THE TORQUE LIMITING HANDLE OFFERED WITH THE SYSTEM, TO PREVENT THE TLS SLEEVE FROM MOVING POST-OPERATIVELY. AN ANTERIOR SUPPORT SCREW CAN BE PLACED IN ADDITION TO THE TLS TO PROVIDE ROTATIONAL STABILITY AND SUPPORT THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FRACTURES WITH LARGE POSTEROMEDIAL (LESSER TROCHANTER) AND POSTEROLATERAL (GREATER TROCHANTER) FRAGMENTS, PREVENTING EXCESSIVE LAG SCREW SLIDING POST-OPERATION. REVIEW OF COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. SEVERAL X-RAYS WERE RECEIVED AND REVIEWED BY A RADIOLOGIST. OVER DIFFERENT TIME POINT IT CAN BE OBSERVED THE FOLLOWING: (B)(6) 2022 - NO INTERVAL CHANGE (B)(6) 2022 - NO INTERVAL CHANGE (B)(6) 2023 - NO INTERVAL CHANGE (B)(6) 2023 - OPERATIVE CHANGE IS PRESENT FROM A PROXIMAL FEMORAL FRACTURE FIXATION WITH INTRAMEDULLARY NAIL AND TWO SCREWS. ALIGNMENT AND HARDWARE POSITION IS ANATOMIC. (B)(6) 2023 - THERE IS INTERVAL CHANGE WITH NEW FEMORAL NECK FORESHORTENING AND VARUS ANGULATION AND VISIBLE OFFSET AT THE MEDIAL FRACTURE. BOTH OF THE SCREWS NOW PENETRATE THE FEMORAL HEAD CONTOUR. (B)(6) 2023 - SINGLE OBLIQUE VIEW CONFIRMS THE FEMORAL HEAD CONTOUR DISRUPTION BY BOTH SCREWS.: INITIAL ANATOMIC ALIGNMENT OF THE POSTOPERATIVE RIGHT HIP FRACTURE FIXATION WITH SUBSEQUENT CHANGE IN FRACTURE ALIGNMENT AND SCREW MIGRATION TRAVERSING THE FEMORAL HEAD CONTOUR. SURGICAL REPORTS WERE NOT PROVIDED. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. A FURTHER AND MORE COMPREHENSIVE INVESTIGATION WAS CARRIED OUT AS PART OF A CA WHICH DETERMINED THAT NO POTENTIAL CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE REQUIRED. THIS DECISION WAS BASED ON THE CONCLUSIONS FROM LITERATURE REVIEW, COMPLAINT REVIEW FROM HCP, AND CURRENT ACCEPTABLE PERFORMANCE OF THE ZNN FORTIS WITH TLS. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MEDWATCH 0009613350-2023-00564-1. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A LAG SCREW THAT PENETRATED THE FEMORAL HEAD. THE PATIENT BEGAN COMPLAINING OF PAIN APPROXIMATELY 8 MONTHS POST-OP. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A LAG SCREW THAT PENETRATED THE FEMORAL HEAD. THE PATIENT BEGAN COMPLAINING OF PAIN APPROXIMATELY 8 MONTHS POST-OP. NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050395 Z NAIL CMF 13MMX21.5CM 130 R TRAUMA PROSTHESIS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3083086 00889024586086

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Prefer Not To Disclose Required Intervention| H SEE H10 NARRATIVE.