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

Model Number	02.12.T3I4R
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 17 april 2020: lot 1907951: (b)(4) items manufactured and released on 17-dec-2019.Expiration date: 2024-12-02.No anomalies found related to the problem.To date, 7 items of the same lot have been already sold without any other similar reported event.Clinical evaluation 1.5 months after primary cemented tka a fracture occurs on the medial tibial epiphysis.Causes of fracture are unknown: the position of the implant and the cuts appear correct on the plain xray supplied, but of course this could not be a very accurate evaluation.No mention in the report of traumatic events.However, we see no hint that this adverse event may be due to a malfunction of the devices.
Event or Problem Description
Revision surgery planned after 2 months from the primary surgery due to tibial subsidence after a tibial head fracture (the cause of the fracture is unknown).The surgeon revised the insert and tibial tray.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10028338
• Report Number: 3005180920-2020-00269
• Device Sequence Number: 777054
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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: No Information
• Device Expiration Date: 12/02/2024
• Device Model Number: 02.12.T3I4R
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 1907951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 05/06/2020
• 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
• Patient Age: 72 YR
• Patient Weight: 85