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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/29/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 331180099
• Report Number: 3005180920-2023-01035
• Device Sequence Number: 1
• Product Code: KRR
• UDI-Device Identifier: 07630040730006
• UDI-Public: 07630040730006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.15.002R
• Device Lot Number: 2112582
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female