MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE4 L; REVISION FEMUR PS

Model Number	02.07.2404L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 february 2020: lot 154241: (b)(4) items manufactured and released on 24-aug-2015.Expiration date: 2020-07-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Other devices involved in the event: gmk-revision 02.07.0684l revision fixed tibial tray cemented size 4 l lot.150586 (k123721).Batch review performed on 16 february 2020: lot 150586: (b)(4) items manufactured and released on 10-apr-2015.Expiration date: 2020-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Gmk-revision 02.07.0417scf fixed tibial insert sc size 4/17mm lot.145730 (k103170).Batch review performed on 16 february 2020: lot 145730: (b)(4) items manufactured and released on 29-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Gmk-revision 02.07.0034rp patella resurfacing size 2 lot.161544 (k090988).Batch review performed on 16 february 2020: lot 161544: (b)(4) items manufactured and released on 09-jun-2016.Expiration date: 2021-05-23.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Gmk-revision 02.07.0003 offset connector 3 mm lot.160317 (k102437).Batch review performed on 16 february 2020: lot 160317: (b)(4) items manufactured and released on 04-apr-2016.Expiration date: 2021-03-09.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Gmk-revision 02.07.0005 offset connector 5 mm lot.155008 (k102437).Batch review performed on 16 february 2020: lot 155008: (b)(4) items manufactured and released on 06-nov-2015.Expiration date: 2020-10-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Gmk-revision 02.07.Fcl15105 extension stem - fluted 15 l 105 lot.154997 (k120790).Batch review performed on 16 february 2020: lot 154997: (b)(4) items manufactured and released on 01-dec-2015.Expiration date: 2020-11-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event since 2016.Gmk-revision 02.07.Fcl14065 extension stem - fluted 14 l 65 lot.136389 (k1207909).Batch review performed on 16 february 2020: lot 136389: (b)(4) items manufactured and released on 18-feb-2014.Expiration date: 2019-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Gmk-revision 02.09.Ta410 tibial augmentation size 4/10mm lot.123246a (k130299).Batch review performed on 16 february 2020: lot 123246a: (b)(4) items manufactured and released on 17-jun-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 other similar reported event since 2016.
Event or Problem Description
Revision surgery after 3 years and 4 months from the primary due to signs of an infection and the pathogen is unknown.The surgery removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.Previously this patient had two revisions due to an infection.During the first the inlay was changed, during the second all the hardware was changed.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE4 L
• Common Device Name: REVISION FEMUR PS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9749832
• Report Number: 3005180920-2020-00101
• Device Sequence Number: 16586174
• Product Code: JWH
• UDI-Device Identifier: 07630030821424
• UDI-Public: 07630030821424
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: Health Professional
• Device Expiration Date: 07/27/2020
• Device Model Number: 02.07.2404L
• Device Catalogue Number: 02.07.2404L
• Device Lot Number: 154241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/25/2020
• 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: 63 YR