MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POROUS CR FEM SZ 7L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 71423247

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

Event Description

It was reported that after tka surgery, it was found out that the patient could have possibly received a lgn porous cr fem sz 7l expired.However, the labeling of the implant contains the wrong expiration date.It was use the same s+n backup device.No patient harm or other complications reported.

Manufacturer Narrative

The associated device, used in treatment, was not returned for evaluation but the reported event could be confirmed through a review of the manufacturing records.A review of the manufacturing records did reveal that the expiration date on the router is 08/2021 but the expiration date on the labels is 12/2020.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is a label system error.This issue was evaluated through our internal quality hold process which found that previous actions have already been taken to address this failure.A new labeling system has been implemented since this event and will eliminate the reoccurrence of this failure.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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: LGN POROUS CR FEM SZ 7L
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11842214
• MDR Text Key: 251199859
• Report Number: 1020279-2021-04382
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00885556032633
• UDI-Public: 00885556032633
• Combination Product (y/n): N
• PMA/PMN Number: K073325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2021
• Device Model Number: 71423247
• Device Catalogue Number: 71423247
• Device Lot Number: 10MHA0008
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1