MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR CR NP FEMORAL COMP SZ 6 LEFT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	71420010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, insufficient clinically relevant information was provided to perform a thorough medical investigation.However, it was reported that the revision was due to infection.The patient impact beyond the reported infection, subsequent revision and likely antibiotic administration cannot be concluded.No further medical assessment is warranted at this time.

• Brand Name: GEN II COCR CR NP FEMORAL COMP SZ 6 LEFT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7243324
• Report Number: 1020279-2018-00121
• Device Sequence Number: 1277036
• Product Code: JWH
• UDI-Device Identifier: 03596010205476
• UDI-Public: 03596010205476
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: 71420010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 05/10/2018
• 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: Hospitalization; Required Intervention