MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR CEMENTED PS SIZE 4NARROW / RIGHT

Catalog Number	02.07.2214R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29-july-2019: lot 132515: (b)(4) items manufactured and released on 01-jul-2013.Expiration date: 2018-05-31.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.Other devices involved in the event.Gmk-revision 02.07.0683r revision fixed tibial tray cemented size 3, lot.182077 (k123721): batch review performed on 29-july-2019.Lot 182077: (b)(4) items manufactured and released on 21-jun-2018.Expiration date: 2023-06-12.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.Gmk-revision 02.09.Ta310 tibial augmentation size 3/10mm, lot.185157 (k130299): batch review performed on 29-july-2019- lot 185157: (b)(4) items manufactured and released on 10-sept-2018.Expiration date: 2023-08-28.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.Gmk-revision 02.07.0003 offset connector 3 mm, lot.187637 (k102437): batch review performed on 29-july-2019- lot 187637: (b)(4) items manufactured and released on 07-nov-2018.Expiration date: 2023-10-23.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.Gmk-revision 02.07.Fcl10105 extension stem - fluted ø 10 l 105 lot.115687 (k120790): batch review performed on 29-july-2019- lot 115687: (b)(4) items manufactured and released on 10-jul-2012.Expiration date: 2017-05-31.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.Gmk-revision 02.07.0317psf tibial insert ps fixed size 3/17mm, lot.182967 (k090988): batch review performed on 29-july-2019- lot 182967: (b)(4) items manufactured and released on 16-jul-2018.Expiration date: 2023-07-02.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.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants 4 months after primary and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR CEMENTED PS SIZE 4NARROW / RIGHT
• Common Device Name: FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8909365
• Report Number: 3005180920-2019-00691
• Device Sequence Number: 1811609
• Product Code: JWH
• UDI-Device Identifier: 07630030820991
• UDI-Public: 07630030820991
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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: 02.07.2214R
• Device Lot Number: 132515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/20/2019
• 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