MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION SCW LWDG S6 5D X 10P; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY

Catalog Number	71421752
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during revision an expired device was implanted on the patient.No delay or injury reported.Back up available.
Additional Manufacturer Narrative
The associated complaint device was not returned.A search was completed and verified the expiration date on this device was 11/12/2018.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Without the actual product involved and/or device information, 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 SCW LWDG S6 5D X 10P
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8237276
• Report Number: 1020279-2019-00115
• Device Sequence Number: 217322
• Product Code: JWH
• UDI-Device Identifier: 03596010545183
• UDI-Public: 03596010545183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2019

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: 11/12/2018
• Device Catalogue Number: 71421752
• Device Lot Number: 08LM09832
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1