MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R E-CROSS; KNEE TIBIAL INSERT E-CROSS

Catalog Number	02.12.E0511FR
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	07/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
About 3 weeks after the primary surgery, the patient came in reporting knee tightness.The surgeon revised the 11mm poly with a 10mm poly and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 2247399: (b)(4) items manufactured and released on 16-feb-2023.Expiration date: 2028-jan-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.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R E-CROSS
• Common Device Name: KNEE TIBIAL INSERT E-CROSS
• 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: 17395201
• Report Number: 3005180920-2023-00561
• Device Sequence Number: 14933122
• Product Code: JWH
• UDI-Device Identifier: 07630971262041
• UDI-Public: 07630971262041
• 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: 2023
• 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): 07/26/2023

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.E0511FR
• Device Lot Number: 2247399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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: 70 YR
• Patient Sex: Male