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

Model Number	02.07.0035RP
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 march 2021: lot 1910555: (b)(4) items manufactured and released on 05-feb-2020.Expiration date: 2025-01-18.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 came in reporting pain due to a loose patella implant and the cause of the loose patella is unknown.8 months after primary the surgeon revised the patella implant and the liner successfully.The tibial insert was not the source of pain but the surgeon felt that it would be better if the size was increased.

• Brand Name: GMK-SPHERE 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: 11582050
• Report Number: 3005180920-2021-00241
• Device Sequence Number: 4157535
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 01/18/2025
• Device Model Number: 02.07.0035RP
• Device Catalogue Number: 02.07.0035RP
• Device Lot Number: 1910555
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/29/2021
• 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: 74 YR