MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 1; PATELLAR IMPLANT

Model Number	02.07.0033RP
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-sep-2021: lot 2100295: (b)(4) items manufactured and released on 06-apr-2021.Expiration date: 2026-03-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Patient match planning review performed by my solution department.The surgeon performed a ct protocol scans and asked a full analysis of them.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
Primary myknee kinematic alignment mri pps blocks performed on (b)(6) 2021, during the 2 weeks follow-up visit the surgeon noticed that the patella implant was dislocating in the last 20% of flexion once the patella leaves the groove.No revision surgery planned at the moment.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 1
• Common Device Name: PATELLAR IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12588871
• Report Number: 3005180920-2021-00795
• Device Sequence Number: 4522449
• Product Code: JWH
• UDI-Device Identifier: 07630030815737
• UDI-Public: 07630030815737
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 03/17/2026
• Device Model Number: 02.07.0033RP
• Device Catalogue Number: 02.07.0033RP
• Device Lot Number: 2100295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/07/2021
• 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: 67 YR
• Patient Weight: 80