MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM; PARTIAL KNEE SYSTEM FEMORAL COMPONENT CEMENTED

Model Number	02.18.003LM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director.One year after cemented uka, intrarticular fluid of unknown origin creates pain and mandates conversion to tka.The cause for the fluid production is unknown but there is no reason to suspect that it be due to an implant defect.The positioning of the uka appears very good, so mechanical origin should be excluded.Batch review performed on 25 november 2021.Lot 1908019: (b)(4) items manufactured and released on 13-nov-2019.Expiration date: 2024-nov-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional components involved: moto partial knee 02.18.If3.08.Lm tibial insert fix s3 lm - 8mm (k162084) lot.187658 lot 187658: (b)(4) items manufactured and released on 15-nov-2018.Expiration date: 2023-nov-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Moto partial knee 02.18.Tf3.Lm tibial tray fix cemented s3 lm (k162084) lot.1908243 lot 1908243: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-dec-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision of a moto to a gmk sphere 1 year 1 month after primary due to unknown intra-articular fluid.No infection was detected.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM
• Common Device Name: PARTIAL KNEE SYSTEM FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13042771
• Report Number: 3005180920-2021-00989
• Device Sequence Number: 12118529
• Product Code: HSX
• UDI-Device Identifier: 07630030895579
• UDI-Public: 07630030895579
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 12/20/2021

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: 11/03/2024
• Device Model Number: 02.18.003LM
• Device Catalogue Number: 02.18.003LM
• Device Lot Number: 1908019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2019
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White