MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 3-4; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420523
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon performed a mua and was able to relocate the knee into it's proper position.However, he was not happy with stability.Dr opened the knee and when going through a range of motion he external rotated the and the femur jumped the post.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicated that no clinical documentation was presented therefore a thorough medical investigation could not be performed.It was reported that an mua was performed post- dislocation.Pt impact beyond the mua cannot be determined.No further medical assessment is warranted at this time.A review of the manufacturing records for the provided batches 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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.

• Brand Name: LEGION CON ART INS 9MM SZ 3-4
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8395484
• Report Number: 1020279-2019-00926
• Device Sequence Number: 16900598
• Product Code: JWH
• UDI-Device Identifier: 03596010555823
• UDI-Public: 03596010555823
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2019

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: 71420523
• Device Lot Number: C1802556
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/23/2019
• 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