MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM; KNEE FEMORAL COMPONENT

Catalog Number	02.18.004LM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed about 1 year and 4 months after the primary surgery due to pain and suspected tibial tray loosening.During the revision surgery, the implants appeared not loose and something else must have been causing pain, but the reason remains unknown.Gmk-sphere with extension stem implanted.
Additional Manufacturer Narrative
Batch review performed on 21 nov 2023: lot 2012098: (b)(4) manufactured and released on 01-feb-2021.Expiration date: 2026-jan-20.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Preliminary investigation performed by r&d project manager: revision surgery of a moto implant after 1 year and 4 months from primary implantation due to pain and suspected tibial loosening.During revision surgery, the tibial was found not loosened, so the cause of pain should have been something different.From the picture sent of the explanted components, sent for investigation, it is not possibile to note any anomalies.From preliminary investigation, there is no evidence or reason to suspect that the event is related to a faulty device.Additional implants involved, batch review performed on 21 nov 2023: moto partial knee 02.18.If3.08.Lm tibial insert fix s3 lm - 8mm (k162084) lot 1910080: (b)(4)manufactured and released on 17-dec-2019.Expiration date: 2024-dec-03.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Moto partial knee 02.18.Tf3.Lm tibial tray fix cemented s3 lm (k162084) lot 2009937: (b)(4)manufactured and released on 01-feb-2021.Expiration date: 2026-jan-20.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: 18333706
• Report Number: 3005180920-2023-00966
• Device Sequence Number: 6739718
• Product Code: HSX
• UDI-Device Identifier: 07630030895593
• UDI-Public: 07630030895593
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2026
• Device Catalogue Number: 02.18.004LM
• Device Lot Number: 2012098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2021
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male