MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 7 LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71423227
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prosthesis was removed due to infection being cleared up in a second stage revision surgery.First stage surgery was purely to treat infection and no components where removed until second stage.
Additional Manufacturer Narrative
The associated legion ps non porous femoral component and genesis ii ps poly tibial base were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Consequently, the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.The related devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LEGION PS NP FEM SZ 7 LT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8712941
• Report Number: 1020279-2019-02337
• Device Sequence Number: 16706052
• Product Code: JWH
• UDI-Device Identifier: 03596010611505
• UDI-Public: 03596010611505
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: 12/05/2025
• Device Catalogue Number: 71423227
• Device Lot Number: 15MM05698
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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