MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION SCW LWDG S4 5D X 10P; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421732
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, after implanted the l-wedges, it was realized that the implant was expired.
Additional Manufacturer Narrative
The associated complaint device was not returned.Complaint was due to user error.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.We consider this investigation closed.Credit cannot be issued for the device.

• Brand Name: LEGION SCW LWDG S4 5D X 10P
• 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: 8307281
• Report Number: 1020279-2019-00456
• Device Sequence Number: 13467586
• Product Code: JWH
• UDI-Device Identifier: 03596010545060
• UDI-Public: 03596010545060
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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: 03/31/2017
• Device Catalogue Number: 71421732
• Device Lot Number: 07DM01574
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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