MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

Catalog Number	02.12.T3I4L
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 october 2019: lot 181873: (b)(4) items manufactured and released on 27-jun-2018.Expiration date: 2023-06-18.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.Other devices involved in the event: gmk-sphere 02.12.0004l femoral component sphere cemented size 4 l lot.180950 (k121416).Batch review performed on 09 october 2019: lot 180950: (b)(4) items manufactured and released on 28-may-2018.Expiration date: 2023-05-16.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 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l lot.180393 (k121416) lot 180393: (b)(4) items manufactured and released on 10-apr-2018.Expiration date: 2023-03-22.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 complaining of anterior knee pain.The cause of the pain is unknown.About 1 year after primary the surgeon resurfaced the patella bone and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9233160
• Report Number: 3005180920-2019-00905
• Device Sequence Number: 2374489
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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: 06/18/2023
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 181873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/24/2019
• 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