MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR PS NP FEMORAL COMPSZ 6 RIGHT; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTEDPOLYMERMETALPOLYMER

Catalog Number	71420122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of smith and nephew devices was performed due to a chronic untreatable infection.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis was conducted and the returned components were examined visually.No destructive analysis was performed.Discoloration was observed on the articular surfaces of the tibial insert.Some damage and deformation was observed on the anterior surface of the tibial insert¿s post.Parallel, semi-circular lines were observed on the superior surface of the tibial baseplate that appear to be scratches.Bone cement was observed on the femoral component and the inferior surfaces of the tibial insert.No material or manufacturing deviations were discovered in this investigation.A clinical evaluation was conducted and without the requested supporting clinical/medical documents, lab, operative report or the explant a thorough investigation of the reported infection cannot be performed rendered.Should information become available this complaint can be re-assessed.Available this complaint can be re-assessed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GEN II COCR PS NP FEMORAL COMPSZ 6 RIGHT
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTEDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8283180
• Report Number: 1020279-2019-00316
• Device Sequence Number: 167874
• Product Code: JWH
• UDI-Device Identifier: 03596010206053
• UDI-Public: 03596010206053
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 71420122
• Device Lot Number: 050M9919
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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
• Patient Age: 74 YR