MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #4/13 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0413FL
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 june 2021.Lot 155441: (b)(4) items manufactured and released on 02-feb-2016.Expiration date: 2021-01-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional device involved.Batch review performed on 14 june 2021.Gmk-sphere 02.07.1204l tibial tray fixed cemented, size 4 l (k090988), lot 2004083: (b)(4) items manufactured and released on 28-aug-20201.Expiration date: 2025-08-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
6 months after the primary, the patient came in reporting instability.The surgeon revised the tibial components.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #4/13 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12126587
• Report Number: 3005180920-2021-00558
• Device Sequence Number: 3592813
• Product Code: JWH
• UDI-Device Identifier: 07630030862618
• UDI-Public: 07630030862618
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: 01/17/2021
• Device Model Number: 02.12.0413FL
• Device Catalogue Number: 02.12.0413FL
• Device Lot Number: 155441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 80