MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0510SF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 jun 2019: lot 168555: (b)(4) items manufactured and released on 14-mar-2017.Expiration date: 2022-02-27.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.Additional implants involved in the event, batch review performed on 06 jun 2019: gmk-primary 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.171962: (b)(4) items manufactured and released on 19-sep-2017.Expiration date: 2022-09-05.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 (complaint (b)(4) [mdr2018-01000]) gmk-primary 02.07.2006r femur std cemented size 6 r (k090988) lot.146902: (b)(4) items manufactured and released on 14-jan-2015.Expiration date: 2019-10-31.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.
Event or Problem Description
The patient was revised on (b)(6) 2018 (3 months after the primary surgery) due to signs of infection and the surgeon subsequently performed an i&d and poly-swap (emdr 2018-01035 was filed).Presently, 6 months after last revision surgery, the patient came in due to signs of infection (the pathogen is unknown).The surgeon revised the tibial tray, femoral component and poly on (b)(6) 2019.We were alerted on (b)(6) 2019.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8691474
• Report Number: 3005180920-2019-00451
• Device Sequence Number: 11266893
• Product Code: JWH
• UDI-Device Identifier: 07630030818240
• UDI-Public: 07630030818240
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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: 02/27/2022
• Device Catalogue Number: 02.07.0510SF
• Device Lot Number: 168555
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/12/2019
• 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