MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII/LEGION RESURF PAT W/JRNY PEG 38MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	71934492
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to a loose patella.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed part.A lab analysis indicated that bone cement was adhered to the bone interfacing surface, and the surrounding material had dents and gouges within it on the bone contacting surface.Slight scratches were shown on the articular surface, which may have been caused by wear from third party particulates in vivo or by removal of the implant.Material damage on either side of the patella as well as bent posts may have been a result of movement of the implant in vivo or caused during extraction.No material or manufacturing defects were observed in the course of this investigation.A clinical analysis indicated that based on the available information, the root cause for the patella "loosening" cannot be concluded at this time.Should any relevant information become available this complaint can be re-assessed.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII/LEGION RESURF PAT W/JRNY PEG 38MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7533703
• Report Number: 1020279-2018-00995
• Device Sequence Number: 184146
• Product Code: JWH
• UDI-Device Identifier: 00885556180266
• UDI-Public: 00885556180266
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2024
• Device Catalogue Number: 71934492
• Device Lot Number: 14DM05502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR