MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 6 L; KNEE TIBIAL TRAY CEMENTED

Catalog Number	02.07.1206L
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2019: lot 134272: (b)(4) items manufactured and released on 08-nov-2013.Expiration date: 2018-09-30.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.Additional implants involved: gmk-revision 02.07.2406l femur revision ps size 6 l (k102437), lot 157217: (b)(4) items manufactured and released on 29-feb-2016.Expiration date: 2021-01-23.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.Gmk-revision 02.07.0612scf fixed tibial insert sc size 6/12mm (k103170), lot 124952: (b)(4) items manufactured and released on 01-mar-2013.Expiration date: 2018-01-31.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.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2017 and she was already revised on (b)(6) 2017 due to pain caused from falling: the surgeon revised the femoral component and poly (mdr 2017-00827).About 1 year and 4 months after that first revision, the patient had another revision surgery due to ruptured patella tendon.Femoral and tibial components swapped successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 6 L
• Common Device Name: KNEE TIBIAL TRAY CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8615711
• Report Number: 3005180920-2019-00381
• Device Sequence Number: 2372474
• Product Code: JWH
• UDI-Device Identifier: 07630030819940
• UDI-Public: 07630030819940
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

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: 09/30/2018
• Device Catalogue Number: 02.07.1206L
• Device Lot Number: 134272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/16/2019
• 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