MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION PROXIMAL BODY HANDLE; HIP SURGICAL INSTRUMENT

Catalog Number 01.22.10.0151

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 4 march 2024 lot 2155926: (b)(4) items manufactured and released on 06-dec-2021.No anomalies found related to the problem.To date, 1 other similar event has been reported on the same lot during the period of review.Preliminary investigation performed by r&d project manager: the proximal body handle 01.22.10.0151 deformed due to the high force applied to the instrument during the disassembly phase.Probably the force required to disassembly the proximal body from the distal stem was higher than expected due to the fact that the implant stayed in the patient 60 days so the modular connection was loaded with the patient weight, further blocking the connection.Additional involved devices batch review performed on 4 march 2024 on m-vizion 01.22.10.0109 disassembly rod lot.2055090 lot 2055090: (b)(4) items manufactured and released on 11-mar-2021.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Batch review performed on 4 march 2024 on m-vizion 01.22.10.0109 disassembly rod lot.2155067 lot 2155067: (b)(4) items manufactured and released on 03-nov-2021.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Batch review performed on 4 march 2024 on stem: m-vizion 01.22.023 proximal body ø24mm l 60mm std (k191816) lot.1901179 lot 1901179: (b)(4) items manufactured and released on 28-nov-2019.Expiration date: 2024-nov-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

During a revision surgery (due to the dislocation of the bipolar head from the acetabular), after completing the acetabular work, the surgeon attempted to disassemble the proximal body from the distal stem, because he wanted to revise also the proximal stem to give more stability to the articulation.The proximal body could not be disassembled and the disassembly rod and the proximal body handle were deformed.Following this attempt, they used the backup handle and another disassembly rod, and again the components couldn't be uncoupled.At this point, they attempted to back off the body with the stem removal instruments but it would not release.The surgeon then decided to leave the m-vizion stem.Only 5 minutes delay reported.The surgeon was satisfied with the result.

• Brand Name: M-VIZION PROXIMAL BODY HANDLE
• Type of Device: HIP SURGICAL INSTRUMENT
• 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: 18993010
• MDR Text Key: 339320747
• Report Number: 3005180920-2024-00163
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07630040739252
• UDI-Public: 07630040739252
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01.22.10.0151
• Device Lot Number: 2155926
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female