MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421377
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient due to set screw backed out of the poly.There was a significant defect on medial aspect of femur so the decision was made to change the femur.No procedure details reported.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, without the requested supporting clinical documents, a thorough medical investigation cannot be rendered.Should any clinical information become available this complaint can be re-assessed.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 parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device 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 HK FEM ASSEMBLY SZ 7 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8651801
• Report Number: 1020279-2019-02090
• Device Sequence Number: 11292146
• Product Code: KRO
• UDI-Device Identifier: 00885556414880
• UDI-Public: 00885556414880
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• 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): 12/09/2019

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: 10/18/2021
• Device Catalogue Number: 71421377
• Device Lot Number: 14EAF0011A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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