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

Model Number	02.07.0035RP
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16.Apr.2021: lot 1907567: (b)(4) items manufactured and released on 2-oct-2019.Expiration date: 18-sep-2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other reported event.
Event or Problem Description
4 months after implantation of the patella implant, it was revised with the competitor product due to pain, patella implant mobilization and instability.The primary surgery was performed on (b)(6) 2016 and the patella implant was installed on (b)(6) 2020.Probably also the liner was revised, but it can't be confirmed.There was no problem with the liner.

• Brand Name: GMK-PRIMARY PATELLA RESURFACING SIZE 3
• Common Device Name: CEMENTED PATELLAR IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11782203
• Report Number: 3005180920-2021-00351
• Device Sequence Number: 19747743
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 05/06/2021

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: 09/18/2024
• Device Model Number: 02.07.0035RP
• Device Catalogue Number: 02.07.0035RP
• Device Lot Number: 1907567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/06/2021
• 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: 69 YR