MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0410FUC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 january 2019: lot 121454: (b)(4) items manufactured and released on 10-aug-2012.Expiration date: 30.06.2017.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Additional component revised (implanted on (b)(6) 2013 - right knee): gmk-primary 02.07.0410fuc tibial insert uc fixed # 4/10 mm (k090988), lot 120150: (b)(6) items manufactured and released on 28-mar-2012.Expiration date: 28.02.2017.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.
Event or Problem Description
The patient came in due to signs of infection 5 years after the primary surgery (10 months after the previous surgery performed by competitor).The pathogen is unknown.The surgeon performed a washout and poly swap on both knees and the surgery was completed successfully.Note: the patient had a primary tka on both his left and right knee in 2013.The patient had a spinal procedure performed by a competitor in 2018 that led to both knees becoming infected.Left knee: (b)(6) 2013, alamance regional med ctr, md michael menz: (lot 121454).Right knee: (b)(6) 2013, alamance regional med ctr, md michael menz: (lot 120150).

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8221849
• Report Number: 3005180920-2018-01069
• Device Sequence Number: 197342
• Product Code: JWH
• UDI-Device Identifier: 07630030817618
• UDI-Public: 07630030817618
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2018

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: 06/30/2017
• Device Catalogue Number: 02.07.0410FUC
• Device Lot Number: 121454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2018
• Initial Report FDA Received Date: 01/07/2019
• 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