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

Catalog Number	02.12.E0410CRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 months after the primary, the patient came in reporting pain and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19 january 2024.Lot 2112621: 25 items manufactured and released on 29-nov-2021.Expiration date: 2026-11-14.No anomalies found related to the problem.To date, 23 items of the same lot have been sold without any similar reported event during the period of review.Additional involved implant.Batch review performed on 19 january 2024 on gmk-sphere 02.12.E002rp patella resurfacing size 2 e-cross (k202022) lot.2242107 lot 2242107: (b)(4) items manufactured and released on 05-dec-2022.Expiration date: 2027-11-22.No anomalies found related to the problem.To date, 104 items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 19 january 2024 on gmk-sphere 02.12.0724l femoral component sphere tinbn coated size 4+ l (k202684) lot.2205191, lot 2205191: (b)(4) items manufactured and released on 05-july-2022.Expiration date: 2027-06-22.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 19 january 2024 on gmk-sphere 02.07.2804l tibial tray fixed cemented size 4 l tinbn coated (k202684) lot.2118549, lot 2118549: (b)(4) items manufactured and released on 23-june-2022.Expiration date: 2027-06-07.No anomalies found related to the problem.To date, 20 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 4/10 MM L
• 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: 18613588
• Report Number: 3005180920-2024-00010
• Device Sequence Number: 7565651
• Product Code: JWH
• UDI-Device Identifier: 07630971261730
• UDI-Public: 07630971261730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

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.E0410CRL
• Device Lot Number: 2112621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2021
• 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 Sex: Female