MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; STEM LOCKING SCREW

Model Number	01.22.201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 04 october 2024: lot 2007105: (b)(4) items manufactured and released on 16-dec-2020.Expiration date: 2026-02-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional devices involved: batch reviews performed on 04 october 2024: m-vizion 01.22.10.0241 trial proximal body ø24mm l 40mm std lot 1954620: (b)(4) items manufactured and released on 07-feb-2020.No anomalies found related to the problem.To date, no similar events have been reported on the same lot.M-vizion 01.22.10.0242 trial proximal body ø24mm l 50mm st lot 1954631: (b)(4) items manufactured and released on 20-oct-2019.No anomalies found related to the problem.To date, no similar events have been reported on the same lot.M-vizion 01.22.10.0243 trial proximal body ø24mm l 60mm std lot 1954632: (b)(4) items manufactured and released on 23-oct-2019.No anomalies found related to the problem.To date, no similar events have been reported on the same lot.M-vizion 01.22.10.0227 trial proximal body ø20mm l 40mm lat lot 1854647: (b)(4) items manufactured and released on 19-dec-2018.No anomalies found related to the problem.To date, no similar events have been reported on the same lot.Lot 1854647b: (b)(4) items manufactured and released on 28-sep-2020.No anomalies found related to the problem.To date, no similar events have been reported on the same lot.M-vizion 01.22.109 distal stem ø20mm l 140mm straight lot 155522: (b)(4) items manufactured and released on 30-march-2017.Expiration date: 2021-02-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.M-vizion 01.22.108 distal stem ø19mm l 140mm straight (k170690) lot 2006793: (b)(4) items manufactured and released on 28-oct-2020.Expiration date: 2025-10-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.M-vizion 01.22.107 distal stem ø18mm l 140mm straight (k170690) lot 2007041: (b)(4) items manufactured and released on 03-feb-2021.Expiration date: 2026-01-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Visual inspection performed by medacta hip r&d project manager: implants were analysed and the results are listed below.- distal stem l140 ø18 ref.01.22.107 (lot 2007041): the thread of the stem was damaged, not possible to insert the screw, the first 3-4 threads are missing (removed).- distal stem l140 ø19 ref.01.22.108 (lot 2006793): the first 3-4 threads are missing (removed).- distal stem l140 ø20 ref.01.22.109 (lot 155522): the shaft of the broken screw was still inside the stem hole, it was removed and the thread was inspected and no major defects found, it was possible to insert a new screw but the screwing was not smooth.- locking screw 01.22.201 (lot 2007105): the screw was found broken at the first thread, the fracture seems to be due to excessive torsional forces.The root cause of the failure is probably due to the treaded rod 01.22.10.0141 that was found with damaged threads, that damaged the distal stem thread during the assembly procedure.The damaged stem thread could have caused the screw to break.Two stems were found with first 3-4 threads missing, probably they were first damaged by the threaded rod and then mechnically removed by the trial screw that cross-threaded into the stem.No actions have been implemented since the root cause is due to a particular condition happened during the surgery.We are monitoring the issue that, up to now, is an isolated case.
Event or Problem Description
Different trial proximal bodies could not be coupled with the final distal stem implant.After many attempts, the locking screw (implant) was used to fix the trial proximal body with the final distal implant.The screw head broke while tightening with the torque wrench.The surgeon removed the whole implant and took an alternative (pre-assembled in back-table) to complete the surgery.1h of delay due to this event.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: STEM LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20369575
• Report Number: 3005180920-2024-00812
• Device Sequence Number: 14389106
• Product Code: LZO
• UDI-Device Identifier: 07630030885143
• UDI-Public: 07630030885143
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2026
• Device Model Number: 01.22.201
• Device Lot Number: 2007105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American