MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM; KNEE TIBIAL INSERT

Catalog Number	02.12.0417FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 5 november 2019.Lot 154783: 50 items manufactured and released on 20 jan 2016.Expiration date: 2021-01-06.No anomalies found related to the problem.To date, 10 items of the same lot have been already sold without any similar reported events.Additional implant involved: gmk-sphere 02.07.F11030 primary extension stem ø11mm / l 30 mm (k133630) lot.182015.Batch review performed on 5 november 2019.Lot 182015: 140 items manufactured and released on 8 may 2018.Expiration date: 2023-04-23.No anomalies found related to the problem.To date, 130 items of the same lot have been already sold without any similar reported events.Additional implant involved: gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416) lot.180377.Batch review performed on 5 november 2019.Lot 180377: 117 items manufactured and released on 23 apr 2018.Expiration date: 2023-04-13.No anomalies found related to the problem.To date, 108 items of the same lot have been already sold without any similar reported events.Additional implant involved: gmk-sphere 02.12.0004r femoral component sphere cemented size 4 r (k121416) lot.180366.Batch review performed on 5 november 2019.Lot 180366: 71 items manufactured and released on 16 apr 2018.Expiration date: 2023-04-05.No anomalies found related to the problem.To date, 65 items of the same lot have been already sold without any similar reported events.Additional implant involved: gmk-sphere 02.07.0033rp patella resurfacing size 1 (k090988) lot.180308.Batch review performed on 5 november 2019.Lot 180308: 130 items manufactured and released on 8 may 2018.Expiration date: 2023-04-25.No anomalies found related to the problem.To date, 124 items of the same lot have been already sold without any similar reported events.
Event or Problem Description
Second revision surgery performed 9 months after the first revision surgery due to an infection and the pathogen is unknown.The surgeon removed all hardware and implanted a new femur and insert to act as a spacer.The first revision surgery was performed due to an infection (insert revised).

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9334341
• Report Number: 3005180920-2019-00980
• Device Sequence Number: 2243956
• Product Code: JWH
• UDI-Device Identifier: 07630030826665
• UDI-Public: 07630030826665
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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 Catalogue Number: 02.12.0417FR
• Device Lot Number: 154783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/18/2019
• 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