MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII/LEGION RESURF PAT W/JRNY PEG 35MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	71934491
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to patella became loose.
Additional Manufacturer Narrative
The associated genesis ii/legion resurfacing patellar component was returned and evaluated.A lab analysis noted scratches, burnishing, and damage were observed on the articular surface and side of the patella.Cement was still covering the entire cement pocket of the implant.No material or manufacturing deviations were observed in the course of this investigation.A clinical evaluation indicated that no patient information or clinical/medical documents has been submitted for review.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number.A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: GII/LEGION RESURF PAT W/JRNY PEG 35MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7284646
• Report Number: 1020279-2018-00221
• Device Sequence Number: 18865924
• Product Code: JWH
• UDI-Device Identifier: 00885556180211
• UDI-Public: 00885556180211
• Combination Product (Y/N): N
• 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): 05/03/2018

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: 02/25/2024
• Device Catalogue Number: 71934491
• Device Lot Number: 14BM20855
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 05/03/2018
• 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: 50 YR