MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP INSTRUMENTS; HIP INSTRUMENT STEM REPOSITIONER

Model Number	01.10.10.190
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During hip primary surgery, the surgeon wanted to remove the stem as it was implanted a wrong size resulting in a too high implant.However, the fixation was good and the surgeon could not get the stem out, using the stem repositioner and screwed stem extractor.After repeated attempts, the stem repositioner had worn out and the stem was left in place.1 hour delay occurred to release all ligaments to increase the leg's leght (total time surgery 2hr and 15min).
Additional Manufacturer Narrative
Batch review performed on 24 sept 2024.Lot 2259820: (b)(4) items manufactured and released on 19-jan-2024.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.
Additional Manufacturer Narrative
On november 22nd 2024 we have received the stem involved in the event.Visual inspection performed by r&d project manager: during the analysis it is evaluated that the plastic clamp of the instrument is completely scratched and deformed.Some debris of plastic are also present on the instrument.It is assumable that the instrument has been used unproperly within a revision surgery to remove a stem that was previously osteointegrated or used with an excessive high traction force.This could be the cause of the deformation and breakage of the plastic part.Additional information received and related to the analysis were added in the event description.
Event or Problem Description
During hip primary surgery, the surgeon wanted to remove the std size 4 stem as it was implanted a wrong size resulting in a too high implant and implant a size 3.However, the fixation was good and the surgeon could not get the stem out, using the stem repositioner and screwed stem extractor.After repeated attempts, the stem repositioner had worn out and the stem was left in place.The device was not damaged before using it.Cup size s and std size 4 stem has been implanted, with the planned offset.One hour delay occurred to release all ligaments to increase the leg's leght (total time sugery 2hr and 15min).

• Brand Name: HIP INSTRUMENTS
• Common Device Name: HIP INSTRUMENT STEM REPOSITIONER
• 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: 20426603
• Report Number: 3005180920-2024-00829
• Device Sequence Number: 7608760
• Product Code: LXH
• UDI-Device Identifier: 07630040746809
• UDI-Public: 07630040746809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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 Model Number: 01.10.10.190
• Device Lot Number: 2259820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian