MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/17 MM L; KNEE TIBIAL INSERT PE

Catalog Number	02.12.0117FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 2 months from the primary, the patient came in reporting pain and instability due to a quad tendon rupture and the cause is unknown.The surgeon is not sure if it is a traumatic event.He performed a quad tendon repair and revised the poly (from insert fixed 17 mm to semiconstrained 23mm) and femorall component.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 february 2024.Lot 1900356: (b)(4) items manufactured and released on 11-apr-2019.Expiration date: 2024-03-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implant revised.Batch review performed on 08 february 2024 on gmk-sphere 02.12.0021l femoral component sphere cemented size 1+ l (k140826) lot.2000498 lot 2000498: (b)(4) items manufactured and released on 28-apr-2020.Expiration date: 2025-04-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/17 MM L
• Common Device Name: KNEE TIBIAL INSERT PE
• 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: 18845577
• Report Number: 3005180920-2024-00082
• Device Sequence Number: 18226100
• Product Code: JWH
• UDI-Device Identifier: 07630030826054
• UDI-Public: 07630030826054
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 03/06/2024

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: 03/27/2024
• Device Catalogue Number: 02.12.0117FL
• Device Lot Number: 1900356
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2019
• 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 Sex: Unknown