MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R E-CROSS

Catalog Number	02.12.E0514FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a torn patella tendon.About 2 months after the primary surgery, the surgeon performed a patella tendon repair and revised the insert (with one of the same thickness).The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10 august 2023.Lot 2211627: (b)(4) items manufactured and released on 02-aug-2022.Expiration date: 2027-jul-11.No anomalies found related to the problem.To date, only this item of the same lot has been sold with no similar reported event during the period of review.Additional implant involved, batch review performed on 10 august 2023: gmk-sphere 02.15.E032 moto e-cross patella d32 (k213071) lot 2110549: (b)(4) items manufactured and released on 28-dec-2021.Expiration date: 2026-dec-14.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 5/14 MM R E-CROSS
• Common Device Name: 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: 17640799
• Report Number: 3005180920-2023-00669
• Device Sequence Number: 20771518
• Product Code: JWH
• UDI-Device Identifier: 07630971262164
• UDI-Public: 07630971262164
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

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.E0514FR
• Device Lot Number: 2211627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2022
• 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: Male
• Patient Weight: 113 KG
• Patient Race: Black Or African American