MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 4; KNEE PATELLA IMPLANT

Model Number	02.07.0036RP
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02-jun-2021: lot 2008651: (b)(4) items manufactured and released on 10-sep-2020.Expiration date: 2025-09-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Mysolution analysis 01-jun-2021: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
Dislocation of the resurfacing patella after the primary surgery performed on (b)(6) 2021.The revision surgery has not planned yet.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: few weeks after primary cemented tka recurring patella dislocation is lamented and revision will be undetyaken.We have not enough information to judge on the possible cause of the problem.Normally, patella dislocations are due to component position, but we have no means to evaluate in this case.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 4
• Common Device Name: KNEE PATELLA IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11918709
• Report Number: 3005180920-2021-00458
• Device Sequence Number: 14431189
• Product Code: JWH
• UDI-Device Identifier: 07630030815775
• UDI-Public: 07630030815775
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 07/22/2021

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: 09/08/2025
• Device Model Number: 02.07.0036RP
• Device Catalogue Number: 02.07.0036RP
• Device Lot Number: 2008651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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
• Patient Age: 75 YR