MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 RIGHT; TIBIAL TRAY FIXED

Catalog Number	02.07.0683R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 24 october 2017.Lot 156557: (b)(4) items manufactured and released on 10 november 2015.Expiration date: 2020-10-27.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 femur revision ps size 2 right, code 02.07.2402r, lot.162493 (k102437) (b)(4) items manufactured and released on 14 june 2016.Expiration date: 2021-06-01.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 fixed tibial insert sc size 3/17mm, code 02.07.0317scf, lot.134139 (k103170) (b)(4) items manufactured and released on 06 december 2013.Expiration date: 2018-10-31.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.Gmk-revision femoral wedge distal size 2/4mm, code 02.07.204fdw, lot.140510 (k102437) (b)(4) items manufactured and released on 07 april 2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on this lot.Gmk-revision offset connector 3 mm, code 02.07.0003, lot.162576 (k102437) (b)(4) items manufactured and released on 26 july 2016.Expiration date: 2021-06-20.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 extension stem - fluted ø 11 l 105, code 02.07.Fcl11105, lot.155888 (k120790) (b)(4) items manufactured and released on 13 january 2016.Expiration date: 2020-12-15.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 femoral wedge distal size 2/8mm, code 02.05.02dw, lot.141936 (k102437) (b)(4) items manufactured and released on 19 may 2014.Expiration date: 2019-04-30.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.Gmk-revision offset connector 5 mm, code 02.07.0005, lot.162577 (k102437) (b)(4) items manufactured and released on 05 july 2016.Expiration date: 2021-06-20.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 extension stem - fluted ø 11 l 65, code 02.07.Fcl11065, lot.162532 (k120790) (b)(4) items manufactured and released on 26 july 2016.Expiration date: 20121-07-07.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 came in due to signs of infection.The pathogen is unknown.The surgeon revised all medacta hardware and implanted a spacer.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 RIGHT
• Common Device Name: TIBIAL TRAY FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6975543
• Report Number: 3005180920-2017-00608
• Device Sequence Number: 900068
• Product Code: JWH
• UDI-Device Identifier: 07630030819377
• UDI-Public: 07630030819377
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: 10/27/2020
• Device Catalogue Number: 02.07.0683R
• Device Lot Number: 156557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/25/2017
• 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