MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM R; KNEE TIBIAL INSERT FIXED

Catalog Number	02.12.0417FR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2021.On (b)(6) 2023, the patient came in reporting instability due to a retinacular tear.The surgeon upsized the poly and resurfaced the patella.Presently, on (b)(6) 2024, the patient came in for a post-op appointment and the surgeon decided to revise all the implants.This because the patient is a fall risk, which mean that she does not walk well overall because of different sensory brain factors such as dizziness or not great balance.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19-aug-2024 lot 2005762: (b)(4) items manufactured and released on 12-aug-2020.Expiration date: 2025-07-27.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.Other devices involved: gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot 2246245: (b)(4) items manufactured and released on 16-mar-2023.Expiration date: 2028-02-27.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.Gmk-sphere 02.12.0004r femoral component sphere cemented size 4 r (k121416) lot 2007024: (b)(6) items manufactured and released on 14-oct-2020.Expiration date: 2025-10-01.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3i4 r (k121416) lot 2008716: (b)(6) items manufactured and released on 27-nov-2020.Expiration date: 2025-11-18.No anomalies found related to the problem.To date, all the 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 4/17 MM R
• Common Device Name: KNEE TIBIAL INSERT FIXED
• 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: 20188926
• Report Number: 3005180920-2024-00721
• Device Sequence Number: 18160053
• Product Code: JWH
• UDI-Device Identifier: 07630030826665
• UDI-Public: 07630030826665
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 09/11/2024

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: 07/27/2025
• Device Catalogue Number: 02.12.0417FR
• Device Lot Number: 2005762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2020
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White