MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION SCW LWDG S4 15D X 10P; PROSTHE, KNEE, PATFEMTIBI, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Catalog Number	71421736
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the nurse realized after implanted that the l-wedges were expired.
Additional Manufacturer Narrative
The associated complaint device was not returned, as in remains in the patient.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The correct expire info for the device was provided and located in the correct areas at the time of manufacture.Most implants are supplied sterile and have been packaged in protective packaging.Nonporous or non-ha coated metal components may be re-sterilized, if necessary, by steam autoclaving in appropriate protective wrapping, after removal of all original packaging and labeling.A review of complaint history on the listed part revealed no prior complaints for the listed part.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.

• Brand Name: LEGION SCW LWDG S4 15D X 10P
• Common Device Name: PROSTHE, KNEE, PATFEMTIBI, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8307328
• Report Number: 1020279-2019-00457
• Device Sequence Number: 154135
• Product Code: JWH
• UDI-Device Identifier: 03596010545107
• UDI-Public: 03596010545107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2017
• Device Catalogue Number: 71421736
• Device Lot Number: 07DM17236
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1