MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE PATELLO FEMORAL JOINT S2 R; KNEE PATELLO FEMORAL JOINT PARTIAL KNEE

Catalog Number	02.15.002R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 6 months after the primary, the patient came in reporting knee pain and displeasure.The surgeon revised patello femoral joint and converted the patient from a partial knee to a total knee and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 december 2023.Lot 2112582: 15 items manufactured and released on 31-jan-2021.Expiration date: 2027-01-19.No anomalies found related to the problem.To date, 13 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: MOTO PARTIAL KNEE PATELLO FEMORAL JOINT S2 R
• Common Device Name: KNEE PATELLO FEMORAL JOINT PARTIAL KNEE
• 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: 18377212
• Report Number: 3005180920-2023-01035
• Device Sequence Number: 7806102
• Product Code: KRR
• UDI-Device Identifier: 07630040730006
• UDI-Public: 07630040730006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K200122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/21/2023

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 Catalogue Number: 02.15.002R
• Device Lot Number: 2112582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2021
• 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 Sex: Female