MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 2

Model Number	02.07.0034RP
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mysolution department analysis performed on 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.Batch review performed on 02-jun-2021 lot 2008647: (b)(4) items manufactured and released on 14-sep-2020.Expiration date: 2025-09-10.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.
Event or Problem Description
Dislocation of the resurfacing patella after primary surgery performed on (b)(6) 2021.Revision surgery has not been planned yet.
Additional Manufacturer Narrative
Clinical evaluation perfored by medacta medical affairs department: few months after primary cemented tka a revision must be scheudled because of recurrent dislocation of patella.The cause for this problem is likely the position of the components, but this cannot be judged with the material available.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 2
• Common Device Name: PATELLA RESURFACING
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11919187
• Report Number: 3005180920-2021-00455
• Device Sequence Number: 4543695
• Product Code: JWH
• UDI-Device Identifier: 07630030815751
• UDI-Public: 07630030815751
• 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: 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): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2025
• Device Model Number: 02.07.0034RP
• Device Catalogue Number: 02.07.0034RP
• Device Lot Number: 2008647
• 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: 07/14/2021
• 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: Other
• Patient Age: 68 YR