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

Model Number	71421244
Medical Device Problem Codes	Contamination (1120); Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery, it was noticed that the legion narrow cr oxin sz 4n lt had a hair inside the sterile package.Smith and nephew backup device available.No surgical delay or injury to patient reported due this event.
Additional Manufacturer Narrative
H3, h6: the associated device, intended for use, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.There is no sign of hair located on the device.The packaging containing the hair was not returned with 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.Possible probable cause could include but not limited to improper handling.Based on this investigation, the need for corrective action is not 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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LEGION NARROW CR 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
• MDR Report Key: 10938842
• Report Number: 1020279-2020-06937
• Device Sequence Number: 17217015
• Product Code: JWH
• UDI-Device Identifier: 00885556233504
• UDI-Public: 00885556233504
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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 Model Number: 71421244
• Device Catalogue Number: 71421244
• Device Lot Number: 20HM00536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1