MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM

Model Number	02.18.IF3.08.RM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 1 month post primary due to pain.The surgeon commented that a slight varus of the tibial baseplate could be the cause of the pain.There was no loosening/mobilization.
Additional Manufacturer Narrative
Batch review performed on 21 december 2022: lot 2201828: (b)(4) items manufactured and released on 21-apr-2022.Expiration date: 2027-03-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional components revised: moto partial knee 02.18.004rm anatomical femoral component cemented s4 rm (k162084) lot.2207902: (b)(4) items manufactured and released on 05-july-2022.Expiration date: 2027-06-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Moto partial knee 02.18.Tf3.Rm tibial tray fix cemented s3 rm (k162084) lot.2201288: (b)(4) items manufactured and released on 04-may-2022.Expiration date: 2027-04-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM
• Common Device Name: PARTIAL KNEE TIBIAL INSERT
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16061013
• Report Number: 3005180920-2022-00990
• Device Sequence Number: 2033883
• Product Code: HSX
• UDI-Device Identifier: 07630030895982
• UDI-Public: 07630030895982
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/28/2022

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 Model Number: 02.18.IF3.08.RM
• Device Catalogue Number: 02.18.IF3.08.RM
• Device Lot Number: 2201828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2022
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian