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

Model Number	02.07.0035RP
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2021: lot 2000632: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-18.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.Additional devices involved batch review performed on 27 may 2021: gmk-sphere 02.12.0005r femoral component sphere cemented size 5 r (k121416) lot 2003235: (b)(4) items manufactured and released on 15-jul-2020.Expiration date: 2025-07-06.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
Tka primary surgery performed using myknee devices for the positioning of the the femoral component, tibial tray and the resurfacing patella.No issue in per-operative was noted then.A post-op control x-ray indicated a dislocation of the resurfacing patella and a femoral rotation of 8¿.Revision surgery was performed on (b)(6) 2021 (6 months after primary).Only the femoral component was removed.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs department: few months after primary cemented tka a partial revision is necessary because the patella luxates from the trochlea.This is probably due to the rotational position of the femoral component.No reason to suspect a faulty device.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 3
• Common Device Name: KNEE PATELLA IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11918707
• Report Number: 3005180920-2021-00454
• Device Sequence Number: 19811140
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 02/18/2025
• Device Model Number: 02.07.0035RP
• Device Catalogue Number: 02.07.0035RP
• Device Lot Number: 2000632
• 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: 07/13/2021
• 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: 61 YR