MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0514FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-feb-2021: lot 189017: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-feb-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs manager: secondary patella resurfacing performed 1 year and 4 months after primary total knee arthroplasty in a (b)(6) years old man.This was caused by intervened arthritis of the patello-femoral joint.During this operation, as customary, the tibial insert has been changed to a new one, but no problem or defect originated this replacement.
Event or Problem Description
Revision surgery performed due to anterior knee pain 1 year and 4 months after the primary.The surgeon resurfaced the patella.The patient already underwent revision surgery due to superficial infection where the inlay was revised in (b)(6) 2019.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 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: 11320736
• Report Number: 3005180920-2021-00113
• Device Sequence Number: 14488190
• Product Code: JWH
• UDI-Device Identifier: 07630030826818
• UDI-Public: 07630030826818
• 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: 2019
• Device Explanted Year: 2021
• 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): 02/12/2021

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: 02/17/2024
• Device Model Number: 02.12.0514FL
• Device Catalogue Number: 02.12.0514FL
• Device Lot Number: 189017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/12/2021
• 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: 63 YR
• Patient Weight: 105