MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

Model Number	02.07.2206L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 3 july 2020 lot 134734: (b)(4) items manufactured and released on 15-nov-2013.Expiration date: 2018-10-30.No anomalies found related to the problem.To date, 17 items of the same lot have been already sold without any other similar reported event since 2016.Other devices involved in the event gmk-primary 02.07.0510apps full-pe ps tibial component #5/10 lot.154056 (k131310) batch review performed by medacta regulatory affairs department on 3 july 2020 lot 154056: (b)(4) items manufactured and released on 17-nov-2015.Expiration date: 2020-11-03.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any other similar reported event since 2016.Gmk-primary 02.07.0035rp patella resurfacing # 3 lot.173028 (k090988) batch review performed by medacta regulatory affairs department on 3 july 2020 lot 173028: (b)(4) items manufactured and released on 5-sep-2017.Expiration date: 2022-08-18.No anomalies found related to the problem.To date, 118 items of the same lot have been already sold without any other similar reported event.Gmk-primary 02.07.0510apps full-pe ps tibial component #5/10 lot.124456 (k131310) batch review performed by medacta regulatory affairs department on 3 july 2020 lot 124456: (b)(4) items manufactured and released on 6-sep-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any other similar reported event since 2016.Gmk-primary 02.07.2206r femur ps cemented # 6 r lot.133888 (k090988) batch review performed by medacta regulatory affairs department on 3 july 2020 lot 133888: (b)(4) items manufactured and released on 7-oct-2013.Expiration date: 2018-08-31.No anomalies found related to the problem.To date, 4 items of the same lot have been already sold without any other similar reported event since 2016.Gmk-primary 02.07.0035rp patella resurfacing # 3 lot.140229 (k090988) batch review performed by medacta regulatory affairs department on 3 july 2020 lot 140229: (b)(4) items manufactured and released on 20-mar-2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, 120 items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
The patient came in 2 years and 6 months after the primary surgery due to signs of infection in both knees and the pathogen is unknown.The surgeon performed bilateral washout and revised all implants.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L
• Common Device Name: FEMUR PS CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10282570
• Report Number: 3005180920-2020-00425
• Device Sequence Number: 485097
• Product Code: JWH
• UDI-Device Identifier: 07630030820885
• UDI-Public: 07630030820885
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: No Information
• Device Expiration Date: 10/30/2018
• Device Model Number: 02.07.2206L
• Device Catalogue Number: 02.07.2206L
• Device Lot Number: 134734
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/16/2020
• 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: 67 YR