MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP INSTRUMENTS; DISASSEMBLY ROD

Model Number	01.22.10.0109
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 march 2025 lot 2250125: (b)(4) items manufactured and released on 23-sep-2022.No anomalies found related to the problem.To date, one similar event has been reported on the same lot during the period of review.Additional item involved in the event, stem: m-vizion 01.22.408 proximal body ø20mm l 50mm lat with holes lot.2409210 lot 2409210: (b)(4) items manufactured and released on 09/09/2024.Expiration date: 20/08/2029.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.Visual inspection the disassembly rod was visibly deformed, a sign of loading beyond the maximum load the bar could bear.This situation can occur when the modular taper junction is so tightened that the disassembly tool cannot disassemble the two parts.It is unclear why the modular taper junction disassembly force was so high.It is probably because the stem was implanted one month before the revision surgery, and during this time, the patient's weight further locked the modular junction, loading it during standing and walking.Studies are ongoing to minimize the occurrence of this event.Root cause: the conditions of surgical variation likely resulted in the applied forces exceeding the inherent limitations of the device resistance as constrained by the collective design inputs.There is no potential manufacturing related cause indicated.
Event or Problem Description
M-vizion stem was implanted on (b)(6) 2025.The patient needed to be revised because was experiencing pain, instability and leg length discrepancy, due to a too short proximal body implanted at the primary surgery.The revision surgery took place 1 month after the primary surgery and the plan was to revise only the proximal body (mdr 2025-00242).However, the disassembly rod bent during proximal stem extraction from the distal body.Despite the attempts, the proximal body could not be removed from the distal stem, therefore the surgeon decided to remove the entire stem (proximal + distal).Surgery was extended by about 15 minutes.

• Brand Name: HIP INSTRUMENTS
• Common Device Name: DISASSEMBLY ROD
• 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: 21717552
• Report Number: 3005180920-2025-00239
• Device Sequence Number: 17307451
• Product Code: LXH
• UDI-Device Identifier: 07630040738958
• UDI-Public: 07630040738958
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/12/2025

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 Model Number: 01.22.10.0109
• Device Lot Number: 2250125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown