MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION NARROW PS OXIN SZ 4N LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421264
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).H6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the legion narrow ps oxin sz 4n lt was labeled on box as a legion narrow ps oxin sz 5n lt but the stickers indicated it was a 4n left narrow femur.The visual also reveals bone cement on the actual implant.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed that the root cause of this issue was that during the reprocessing of the outer labels for batches 23em09868 and 23em09878, a paperwork or labeling mix occurred resulting in the reprinted labels being applied to the incorrect product.The standard rework process was not followed and a new rework order was not created and label verification was not performed.Final visual inspection failed to identify the discrepancy.This issue was identified and is being addressed though our internal quality process.According to label specification, the size on the outer label should be 4n.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.At this time, we do have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that during a tka surgery, the legion narrow ps oxin sz 4n lt was labeled on box as a legion narrow ps oxin sz 5n lt, but just before implanting it, the surgeon noticed that the stickers indicated it was a 4n left narrow femur.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device reveals the legion narrow ps oxin sz 4n lt was labeled on box as a legion narrow ps oxin sz 5n lt but the stickers indicated it was a 4n left narrow femur.The visual also reveals bone cement on the actual implant.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed that the root cause of this issue was that during the reprocessing of the outer labels for batches 23em09868 and 23em09878, a paperwork or labeling mix occurred resulting in the reprinted labels being applied to the incorrect product.The standard rework process was not followed and a new rework order was not created and label verification was not performed.Final visual inspection failed to identify the discrepancy.A field action was initiated to voluntarily remove one batch of legion narrow ps oxin sz 5n lt due to the packaging error.According to label specification, the size on the outer label should be 4n.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.At this time, we do have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LEGION NARROW PS OXIN SZ 4N LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17774704
• Report Number: 1020279-2023-01787
• Device Sequence Number: 7433867
• Product Code: JWH
• UDI-Device Identifier: 00885556233955
• UDI-Public: 00885556233955
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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 Catalogue Number: 71421264
• Device Lot Number: 23EM09868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown