MAUDE Adverse Event Report: SMITH & NEPHEW, INC LGN REV TIBIA BASE SZ 6 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71424016
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery fo right knee was performed due to infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A clinical assessment noted that no clinically relevant information has been provided for inclusion in this investigation.However, two undated x-rays provided do not contribute to this investigation.The causal relationship between the smith and nephew devices and the reported infection approximately nine years post implantation cannot be determined.No further clinical investigation is warranted at this time.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Products were sterilized according to sterilization release documentation from quality control.Without the return of the actual products involved, 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.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN REV TIBIA BASE SZ 6 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC; 1450 brooks road; memphis TN
• MDR Report Key: 7846494
• Report Number: 1020279-2018-01707
• Device Sequence Number: 11086119
• Product Code: JWH
• UDI-Device Identifier: 03596010546180
• UDI-Public: 03596010546180
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K04340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/21/2019

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: 71424016
• Device Lot Number: 18BM02814
• Initial Date Received by Manufacturer: 08/11/2018
• Supplement Date Received by Manufacturer: 08/11/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 05/21/2019
• 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