MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0412CRR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years 9 months after the primary, the patient came in reporting pain due to knee instability and loose patella and the cause of the instability and loose patella is unknown.The surgeon revised the patella and insert (12mm to 17mm).The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 188612:(b)(4).Expiration date: 2024-01-24.No anomalies found related to the problem.To date, 63 items of the same lot have been sold without any similar reported event during the period of review.Additional device involved: batch review performed on (b)(6) 2023: gmk-sphere 02.07.0035rp patella resurfacing siye 3 (k090988) lot 2000631: 239 items manufactured and released on (b)(6) 2020.Expiration date: 2025-02-12.No anomalies found related to the problem.To date, 235 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17258642
• Report Number: 3005180920-2023-00472
• Device Sequence Number: 7966755
• Product Code: JWH
• UDI-Device Identifier: 07630040707527
• UDI-Public: 07630040707527
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 07/04/2023

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: 01/24/2024
• Device Model Number: 02.12.0412CRR
• Device Catalogue Number: 02.12.0412CRR
• Device Lot Number: 188612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 121 KG