MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL SIZE E LM/RL; PROSTHESIS KNEE FEMOROTIBIAL NONCONSTRAINED CEMENTED METALPOLYMER

Catalog Number	00584201501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to an infection.No product issues suspected.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: FEMORAL SIZE E LM/RL
• Common Device Name: PROSTHESIS KNEE FEMOROTIBIAL NONCONSTRAINED CEMENTED METALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8220543
• Report Number: 1020279-2019-00069
• Device Sequence Number: 1961362
• Product Code: HSX
• UDI-Device Identifier: 00885556619919
• UDI-Public: 00885556619919
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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 Expiration Date: 09/30/2022
• Device Catalogue Number: 00584201501
• Device Lot Number: 62172897
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/05/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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; Other; Required Intervention
• Patient Age: 66 YR