MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R; TIBIAL INSERT PS FIXED

Model Number	02.12.0311FR
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by regulatory affairs department on 3 june 2020: lot 1902497: (b)(4) items manufactured and released on 17-jun-2019.Expiration date: 2024-05-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implants involved in the event, batch review performed by regulatory affairs department on 3 june 2020: gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r (k121416) lot.1904585 lot 1904585: (b)(4) items manufactured and released on 18-sep-2019.Expiration date: 2024-09-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.1906231 lot 1906231: (b)(4) items manufactured and released on 27-nov-2019.Expiration date: 2024-11-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have sbeen sold without any similar reported event.
Event or Problem Description
He patient came in reporting pain 4 months after the primary surgery and the cause of pain is unknown.The surgeon revised the femoral component, tibial tray and insert and converted the patient to a hinge knee.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R
• Common Device Name: TIBIAL INSERT PS FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10156627
• Report Number: 3005180920-2020-00335
• Device Sequence Number: 19538960
• Product Code: JWH
• UDI-Device Identifier: 07630030862588
• UDI-Public: 07630030862588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

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: 05/27/2024
• Device Model Number: 02.12.0311FR
• Device Catalogue Number: 02.12.0311FR
• Device Lot Number: 1902497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/16/2020
• 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