MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/14 MM R

Model Number	02.12.0214FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 november 2020: lot 175251: (b)(4) items manufactured and released on 11-jan-2018.Expiration date: 2022-12-11.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.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The patient also reported anterior knee pain and the cause of the anterior knee pain is unknown.The surgeon performed a washout and removed the gmk-sphere tibial insert - flex s2r - 14mm, and upsized it to a gmk-sphere tibial insert - flex s2r - 17 mm, to help alleviate the anterior knee pain 1 year and 1 month after previous surgery.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/14 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10928278
• Report Number: 3005180920-2020-00862
• Device Sequence Number: 16341372
• Product Code: JWH
• UDI-Device Identifier: 07630030826221
• UDI-Public: 07630030826221
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2022
• Device Model Number: 02.12.0214FR
• Device Catalogue Number: 02.12.0214FR
• Device Lot Number: 175251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/01/2020
• 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: 64 YR