MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ3 LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421213
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the implant was found with the outer sealing lid adhered to the inner sealing lid.No delay nor injury reported.The implant was used with the compromised sterile barrier, no infection has been reported.
Additional Manufacturer Narrative
The associated packaging for the device was returned and evaluated.A visual inspection of the returned packaging could not confirm the stated failure mode.Only the inner tray lids were returned for evaluation.One corner of both lids was bent over.The lids were slightly stuck together.Without the trays, a sterile breach could not be confirmed.The device were manufactured in 2017.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 have no 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 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.

• Brand Name: LEGION PS OXIN FEM SZ3 LT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9258170
• Report Number: 1020279-2019-03847
• Device Sequence Number: 14385349
• Product Code: JWH
• UDI-Device Identifier: 00885556030899
• UDI-Public: 00885556030899
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 71421213
• Device Lot Number: 17EM12355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1