MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 11MM BOLT - SLEEVE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421385
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a set screw backed out of the tibial baseplate but stayed contained in the poly.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A review of the complaint history revealed no prior complaints for the listed lot.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our clinical/medical team concluded: one undated x-ray photo was provided and confirms the report.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause for the reported set screw backing out of the tibial baseplate cannot be determined.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.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.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LEGION HK 11MM BOLT - SLEEVE
• 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: 8295409
• Report Number: 1020279-2019-00365
• Device Sequence Number: 2463455
• Product Code: KRO
• UDI-Device Identifier: 00885556029213
• UDI-Public: 00885556029213
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 71421385
• Device Lot Number: 12MTM004
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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