MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 8 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71423238
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a serious injury in which femoral component was revised due to infection.It was revised to a legion constrained femoral.
Additional Manufacturer Narrative
The affected legion ps non-porous femoral component was not returned for evaluation.A clinical evaluation noted that no relevant clinical information was provided to conduct a thorough clinical investigation.The impact to the patient beyond the revision and the reported infection cannot be concluded. no further clinical/medical assessment is warranted at this time.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.Credit cannot be issued for this device.

• Brand Name: LEGION PS NP FEM SZ 8 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7737242
• Report Number: 1020279-2018-01452
• Device Sequence Number: 2770681
• Product Code: JWH
• UDI-Device Identifier: 00885556031391
• UDI-Public: 00885556031391
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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 Catalogue Number: 71423238
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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