MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R TINBN COATED; KNEE TIBIAL TRAY

Model Number	02.07.2804R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 february 2021: lot 174148: (b)(4) items manufactured and released on 06-dec-2017.Expiration date: 2022-11-26.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.Clinical evaluation performed by medacta medical affairs director: early subsidence of tibial component in primary cemented tka, few weeks after primary.The medial bone subsided; the significant presence of osteophytes may have conditioned component sizing and the quality of the bone could have been lower than expected.No reason to suspect a faulty device as the root cause of this case.
Event or Problem Description
Revision surgery performed 1 month after the primary surgery due to the subsidence of the tibial tray (the cause is unknown but it is possible that the tibial tray was undersized).All implants have been revised.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R TINBN COATED
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11474012
• Report Number: 3005180920-2021-00186
• Device Sequence Number: 3679005
• Product Code: JWH
• UDI-Device Identifier: 07630030821837
• UDI-Public: 07630030821837
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/12/2021

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: 11/26/2022
• Device Model Number: 02.07.2804R
• Device Catalogue Number: 02.07.2804R
• Device Lot Number: 174148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/12/2021
• 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: 64 YR
• Patient Weight: 100