MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 13MM BOLT - SLEEVE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421386
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection and all parts were removed.Patient received antibiotic spacer.
Additional Manufacturer Narrative
The information was being reviewed by the manufacturer and has identified that this event should be re-evaluated for mdr reporting.The information states that this incident was already reported under the report 1020279-2019-01492, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: LEGION HK 13MM BOLT - SLEEVE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8497979
• Report Number: 1020279-2019-01496
• Device Sequence Number: 1019093
• Product Code: KRO
• UDI-Device Identifier: 00885556109144
• UDI-Public: 00885556109144
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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 Catalogue Number: 71421386
• Device Lot Number: 16JTM0051C
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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: Hospitalization; Required Intervention