MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R; KNEE FIXED CEMENTED TIBIAL TRAY

Catalog Number	02.12.T4I3R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 march 2019: lot 131501: (b)(4).No anomalies found related to the problem.(b)(4) two additional items were involved in the complaint: gmk-sphere 02.12.0310fr tibial insert fixed sphere flex size 3/10 mm, lot 141804, (k121416): (b)(4).No anomalies found related to the problem.To date, all the items of this lot have already been sold without any other similar event reported.Gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r, lot 142546, (k121416): (b)(4).No anomalies found related to the problem.To date, all the items of this lot have already been sold without any other similar event reported.
Event or Problem Description
On (b)(6) 2019 we were informed about a patient who needed a revision 4 years and 6 months after the primary due to infection (the pathogen is unknown).On the following day the tibial tray, insert and femoral component have been revised.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R
• Common Device Name: KNEE FIXED CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8420921
• Report Number: 3005180920-2019-00151
• Device Sequence Number: 277542
• Product Code: JWH
• UDI-Device Identifier: 07630030827167
• UDI-Public: 07630030827167
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 02.12.T4I3R
• Device Lot Number: 131501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/14/2019
• 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
• Patient Age: 63 YR