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

Model Number	02.07.0033RP
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 march 2021: lot 1901655: (b)(4) items manufactured and released on 03-may-2019.Expiration date: 2024-04-21.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 device involved: batch reviews performed on 04 march 2021: gmk-sphere 02.12.0002r femoral component sphere cemented size 2 r (k121416) lot 188959: (b)(4) items manufactured and released on 17-jan-2019.Expiration date: 2023-12-18.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.Gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot 1901597: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-07-03.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.Gmk-sphere 02.12.0210fr tibial insert fixed sphere flex size 2/10 mm r (k121416) lot 1901312: (b)(4) items manufactured and released on 06-jun-2019.Expiration date: 2024-05-19.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
The patient came in reporting pain and the cause of the pain is unknown.The surgeon removed all the implants, revised them with new implants, and added extension stems, offset connectors and a tibial cone 1 year and 5 months after primary.The surgery was completed successfully.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 1
• Common Device Name: KNEE PATELLA IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11551131
• Report Number: 3005180920-2021-00233
• Device Sequence Number: 3932315
• Product Code: JWH
• UDI-Device Identifier: 07630030815737
• UDI-Public: 07630030815737
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: 04/21/2024
• Device Model Number: 02.07.0033RP
• Device Catalogue Number: 02.07.0033RP
• Device Lot Number: 1901655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/23/2021
• 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