MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CEMENT STEM10MMX160MM STRT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	71424202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery performed due to infection.All implants removed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional medical information be provided these complaints will be re-assessed.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: LGN CEMENT STEM10MMX160MM STRT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9036284
• Report Number: 1020279-2019-03348
• Device Sequence Number: 2204231
• Product Code: JWH
• UDI-Device Identifier: 03596010547057
• UDI-Public: 03596010547057
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• 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): 11/26/2019

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: 71424202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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: Required Intervention