MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0310FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 march 2024.Lot 2113258: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-11-01.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.Clinical evaluation performed by medical affairs department less than two years after primary cemented tka, resulting in a valgus alignment of the knee (no preoperative xray or information is available), the patient complains of pain and reduced rom and a surgeon different from the primary surgeon undertakes a revision procedure.The components are found stable, so the surgeon proceeds to work on soft tissues to improve rom and resurfaces the patella.The causes of limited rom are probably to be sought in the soft tissues surrounding the implant, or in the patella itself.We cannot express an opinion on the component orientation or position because we have no pre-primary information.
Event or Problem Description
Revision surgery for pain in the right knee and reduced range of motion (rom).At 1 year and 10 months post primary, switch of the tibial insert with a new e-cross liner of the same thickness and resurfacing of patella bone.The surgeon tried to remove some tissue mainly around the posterior condyles of the femur, "cleaned" as much as possible and the rom was slightly improved.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 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: 19048913
• Report Number: 3005180920-2024-00175
• Device Sequence Number: 8549033
• Product Code: JWH
• UDI-Device Identifier: 07630030826344
• UDI-Public: 07630030826344
• 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: 2022
• 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): 04/05/2024

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 Catalogue Number: 02.12.0310FR
• Device Lot Number: 2113258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• 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: 63 YR
• Patient Sex: Female