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

Model Number	02.12.T3I4L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 may 2018: lot 168375: (b)(4) items manufactured and released on 25 april 2017 expiration date: 2022-04-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
Event or Problem Description
The patient came in reporting instability due to a loose tibia.The cause of the loose tibia is unknown.The surgeon revised the medacta tibial tray fixed cemented # t3-i4 l with a medacta rev.Tibial tray left s3 and a medacta sphere insert flex left 12mm s4 with a medacta sphere insert flex left 14mm s3 almost 2 years and a half after primary.The surgeon also added augments and an extension stem.The surgery was completed successfully.
Additional Manufacturer Narrative
On 30-mar-2020 we noticed that the batch review date reported in the initial report was wrong.The reported date was 03 may 2018, the correct one is 16 january 2020.Here below you can find the batch review with the correct date batch review performed on 16 january 2020 lot 168375: 79 items manufactured and released on 25 april 2017 expiration date: 2022-04-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9693710
• Report Number: 3005180920-2020-00039
• Device Sequence Number: 2844659
• 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: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 04/09/2022
• Device Model Number: 02.12.T3I4L
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 168375
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/30/2020
• 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