MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION SCW LWDG S6 5D X 10P; PROSTHSSKNEEPATLLOEMOOTIBLSMICNSTINDCMENTDPLYMRMTALPLYMR

Model Number	71421752
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision surgery, with the surgeon's approval, an expired wedge was implanted.The packaging was perfect.The seal and plastic lid was intact and in perfect condition.Surgeon was fully aware that the product was expired and wanted to move forward with the procedure.No delay.No injury to patient reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation as it remains in use.A clinical analysis indicated that reportedly during a tkr an expired wedge was implanted.It has been communicated that "the surgeon was fully aware that the product was expired and wanted to move forward with the procedure." per e-mail communication the surgeon is satisfied with the outcome and the patient is doing well following the revision.Since no patient harm is being reported and no adverse consequence is anticipated as a result of this occurrence, no further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.All labeling and expiration dates were verified as correct.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions of use for the product were completed.Factors and/or some potential probable causes that could include but not limited to user error.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: LEGION SCW LWDG S6 5D X 10P
• Common Device Name: PROSTHSSKNEEPATLLOEMOOTIBLSMICNSTINDCMENTDPLYMRMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9433406
• Report Number: 1020279-2019-04321
• Device Sequence Number: 2579203
• Product Code: JWH
• UDI-Device Identifier: 03596010545183
• UDI-Public: 03596010545183
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K041106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 07/28/2018
• Device Model Number: 71421752
• Device Catalogue Number: 71421752
• Device Lot Number: 08GM22330
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1