MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE PATELLA RESURFACING SIZE 3; PATELLA IMPLANT

Model Number	02.07.0035RP
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 may 2021: lot 1902823: (b)(4) items manufactured and released on 25-jun-2019.Expiration date: 2024-06-09.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
The patient had a primary knee surgery and was implanted with competitor implants.On (b)(6) 2019, the patient had the competitor implants revised to medacta implants for reasons unknown.The surgery was completed successfully.The patient came in reporting pain due to a patella dislocation and the cause of the patella dislocation is unknown.1 year and 6 months after medacta implant insertion the surgeon revised the femoral component, insert, and added extension stem, distal femoral wedge, and posterior femoral wedge.The surgery was completed successfully.

• Brand Name: GMK-HINGE PATELLA RESURFACING SIZE 3
• Common Device Name: PATELLA IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11877232
• Report Number: 3005180920-2021-00427
• Device Sequence Number: 14349884
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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: 06/09/2024
• Device Model Number: 02.07.0035RP
• Device Catalogue Number: 02.07.0035RP
• Device Lot Number: 1902823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention