MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 2 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	71424002
Health Effect - Clinical Codes	Bacterial Infection (1735); Hematoma (1884); Pain (1994); Scar Tissue (2060); Swelling (2091)
Date of Event	07/14/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.
Event or Problem Description
It was reported that a surgery was performed to clean out hematoma and remove scar tissue due to pain, swelling.
Additional Manufacturer Narrative
Examination was not possible, as the devices were not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history records was performed which confirmed no inconsistencies.No further investigation is warranted at this time.
Event or Problem Description
It was reported that the patient has undergone a revision surgery to remove components of the construct due to a bacterial infection on (b)(6) 2017.
Additional Manufacturer Narrative
Please refer to mdr 1020279-2016-00026.Same patient, same construct and event.
Additional Manufacturer Narrative
Please review attached for the investigation results.

• Brand Name: LGN REV TIBIA BASE SZ 2 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 5349094
• Report Number: 1020279-2016-00013
• Device Sequence Number: 632387
• Product Code: JWH
• UDI-Device Identifier: 03596010546067
• UDI-Public: 03596010546067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Followup
• Report Date (Section B): 04/02/2018

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: 11/08/2021
• Device Catalogue Number: 71424002
• Device Lot Number: 11LM06663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2016
• Supplement Report FDA Received Date: 04/04/2016
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71424002/11LM06663.; 71424023/14DSM0189B.; 71424025/13HSM0191.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female