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

Catalog Number	02.12.T4I3L
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 september 2018; lot 140308: (b)(4) items manufactured and released on 02 may 2014.Expiration date: 2019-03-31; 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.Other devices involved: femoral component sphere cemented size 3+ l reference 02.12.0023l (k140826); lot 151962: (b)(4) items manufactured and released on 13 april 2015.Expiration date: 2020-02-29.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.Tibial insert fixed sphere flex size 3/12 mm l reference 02.12.0312fl (k121416); lot 134431: (b)(4) items manufactured and released on 13 november 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.Clinical evaluation performed by medical affairs (b)(4) on 13 septemebr 2018; knee revision surgery occurred 2 years after cemented total knee arthroplasty in a heavy (b)(6) year old patient.According to the report, the cause of revision is ligament laxity that required a more constrained knee system.This diagnosis seems very convincing given the previous operations that this knee was subjected to.
Event or Problem Description
Revision surgery performed due to ligaments laxity 2 years and 3 months after primary surgery.Gmk-sphere was replaced by a gmk-hinge.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 L
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7872477
• Report Number: 3005180920-2018-00679
• Device Sequence Number: 1940038
• Product Code: JWH
• UDI-Device Identifier: 07630030827150
• UDI-Public: 07630030827150
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

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: 03/31/2019
• Device Catalogue Number: 02.12.T4I3L
• Device Lot Number: 140308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/13/2018
• 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: 61 YR
• Patient Weight: 116