MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RIGHT-MEDIAL

Catalog Number	02.18.005RM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 18 august 2017.Lot 163688: (b)(4) items manufactured and released on 24 october 2016.Expiration date: 2021-06-15.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.Moto partial knee - tibial tray fix cemented s6 right-medial, code 02.18.Tf6.Rm, lot.160699 (k162084) (b)(4) items manufactured and released on 24 october 2016.Expiration date: 2021-05-29.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.Moto partial knee - tibial insert fix s6 - 8mm right-medial, code 02.18.If6.08.Rm, lot.161238 (k162084) (b)(4) items manufactured and released on 24 october 2016.Expiration date: 2021-06-08.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 came in due to signs of infection.The pathogen is unknown.The surgeon removed all medacta hardware and implanted another product.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RIGHT-MEDIAL
• Common Device Name: ANATOMICAL FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6803618
• Report Number: 3005180920-2017-00452
• Device Sequence Number: 11193378
• Product Code: HSX
• UDI-Device Identifier: 07630030895623
• UDI-Public: 07630030895623
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

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: 06/15/2021
• Device Catalogue Number: 02.18.005RM
• Device Lot Number: 163688
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/18/2017
• 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