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

Catalog Number	71934491
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the pegs broke off of the patella.A backup device was available.No delay was reported.A revision surgery had to be performed due to this failure mode.
Event or Problem Description
A revision surgery had to be performed due to the pegs broke off of the patella.A backup device was available.No delay was reported.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, the as received component showed little to no damage along the articular surface.A post is deformed and two posts are fractured, one of which is cleaved at the bone interface while the other deformed in the same direction as the remaining post before fracture.The bone-contacting surface of the component showed bone cement within the implant and a damaged surface.No material or manufacturing defects were observed in the course of this investigation.The clinical/medical team concluded, no relevant clinical medical information was provided to conduct a thorough medical assessment.The device was returned and the product evaluation revealed no material or manufacturing defects were observed in the course of this investigation.If new information is received in the future, this complaint can be re-opened.

• Brand Name: GII/LEGION RESURF PAT W/JRNY PEG 35MM
• 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: 8244731
• Report Number: 1020279-2019-00153
• Device Sequence Number: 2370193
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2019

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 Catalogue Number: 71934491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 12/17/2018; 12/17/2018
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 01/16/2019; 05/14/2019
• 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