MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 7 LT; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number 71423227

Device Problem Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2020

Event Type  malfunction  

Event Description

It was reported that the device was contained in a package with expiration time for 2025.When scanning, the implant item was found to be marked as expired on the system since 2016.No case related.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2015 and was returned unused in its original packaging.The sterilization date on the box corresponds to the date of manufacture.The product evaluation confirmed the stated failure mode.The expiration date in sap does not match what is on the device.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable cause for this event is likely human error.Based on this investigation, the need for corrective action is indicated.The expiration date in sap has been corrected.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LEGION PS NP FEM SZ 7 LT
• Type of Device: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10012387
• MDR Text Key: 189430456
• Report Number: 1020279-2020-01401
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010611505
• UDI-Public: 03596010611505
• Combination Product (y/n): N
• PMA/PMN Number: K060742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2016
• Device Model Number: 71423227
• Device Catalogue Number: 71423227
• Device Lot Number: 15LM13603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1