MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/17 MM R; KNEE TIBIAL LINER

Model Number	02.12.0217FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15.Feb.2021: lot 154771: (b)(4) items manufactured and released on 20-jan-2016.Expiration date: 2021-01-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional devices involved batch reviews performed on 15.Feb.2021: gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot 182896: (b)(4) items manufactured and released on 12-sep-2018.Expiration date: 2023-09-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.12.0022r femoral component sphere cemented size 2+ r (k140826) lot 181857: (b)(4) items manufactured and released on 13-jun-2018.Expiration date: 2023-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in 2 months after previous revision surgery (primary in 2018) due to signs of an infection and the pathogen is unknown.The surgeon removed all the implants except the patella and implanted an antibiotic spacer.The surgery was completed successfully.This is the 3rd revision surgery for this patient.The previous revisions were performed due to quad tendon repair (inset revised) and infection (washout and insert revision).

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/17 MM R
• Common Device Name: KNEE TIBIAL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11331084
• Report Number: 3005180920-2021-00125
• Device Sequence Number: 10968507
• Product Code: JWH
• UDI-Device Identifier: 07630030826269
• UDI-Public: 07630030826269
• Combination Product (Y/N): N
• 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: 2020
• 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): 02/16/2021

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: 01/06/2021
• Device Model Number: 02.12.0217FR
• Device Catalogue Number: 02.12.0217FR
• Device Lot Number: 154771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/16/2021
• 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