MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0410FR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-dec-2023: lot 1810394: (b)(4) items manufactured and released on 14-mar-2019.Expiration date: 2024-03-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of the review.
Event or Problem Description
At about 4 years and 10 months after primary, the patient was revised because of instability.The liner was changed with a thicker one (10mm to 14mm) and patellar bone has been resurfaced.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 04 january 2024: 5 years after primary cemented tka, instability develops and probably also (unreported) anterior knee pain.The surgeon proceeds then to secondary resurfacing of patella and to augment the joint stability with a thicker insert.Both causes (secondary anterior knee pain and secondary ligament laxity) are normal disease progression and the reoperation was therefore not caused by a failure of the former treatment.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 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: 18386908
• Report Number: 3005180920-2023-01027
• Device Sequence Number: 17148861
• Product Code: JWH
• UDI-Device Identifier: 07630030826542
• UDI-Public: 07630030826542
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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: 03/03/2024
• Device Catalogue Number: 02.12.0410FR
• Device Lot Number: 1810394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2019
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 81 KG