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

Model Number	02.07.0035RP
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 may 2021: lot 2011821: (b)(4) items manufactured and released on 04-jan-2021.Expiration date: 2025-12-09.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 review performed on 10 may 2021: gmk-sphere 02.12.0314fl tibial insert fixed sphere flex size 3/14 mm l (k121416) lot 2005743: (b)(4) items manufactured and released on 03-sep-2020.Expiration date: 2025-08-20.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 due to a dislocated patella.The cause of the dislocated patella is unknown.The surgeon performed an osteotomy of the tibia to change tracking and revised the insert with a 17mm one the day after primary surgery.The surgery was completed successfully.There was a bit of instability and the surgeon wanted to give the patient more stability so he upsized the poly and, instead of using augments, the surgeon performed a tibial osteotomy and used hip screws to hold it back together.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 3
• Common Device Name: KNEE PATELLA IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11884443
• Report Number: 3005180920-2021-00434
• Device Sequence Number: 3632970
• 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: 2021
• 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): 05/26/2021

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: 08/20/2025
• Device Model Number: 02.07.0035RP
• Device Catalogue Number: 02.07.0035RP
• Device Lot Number: 2011821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/26/2021
• 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