MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 14MM X 160MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER METAL

Catalog Number	71424047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to knee joint pseudarthrosis.The surgeon decided it is not the product failure.The products was returned to the patient after the surgery so it cannot be returned.No more information is available.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, it has been communicated via email that no relevant supporting clinical information will be provided, and was further reported that the patient has recovered.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: LGN PRESSFIT STEM 14MM X 160MM
• 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: 7564034
• Report Number: 1020279-2018-01040
• Device Sequence Number: 13497323
• Product Code: JWH
• UDI-Device Identifier: 03596010546791
• UDI-Public: 03596010546791
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 07/15/2018

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: No Information
• Device Catalogue Number: 71424047
• Device Lot Number: 16MSM0466A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/03/2018
• Supplement Report FDA Received Date: 07/16/2018
• 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