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
Dr revised gen 2 cr tkr to a legion revision femur, constrained insert ( compromised lateral collateral) and kept the original tibial baseplate.While the patient was doing their physio ( leg extension ) the femur jumped the post on the poly.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.The poly was upsized to a 13mm constrained insert, and stability was regained.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinical documentation was presented therefore a thorough medical investigation could not be performed.It was reported that a first revision had been performed; however details remain unknown.The second revision included an increased poly component (9mm to 13 mm) for instability post mua (c-234116 & c-234120) and provided appropriate stability per report.Pt impact was the revision procedure.No further medical assessment is warranted at this time.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.We consider this investigation 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: 8395301
• Report Number: 1020279-2019-00923
• Device Sequence Number: 192796
• 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): 06/25/2019

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: 02/11/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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