MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT RT 5-6 11M; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74029253
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the surgeon stated that the insert swapped out in conjunction with patella component swap.There was no delay nor injury reported.A smith and nephew backup was used.
Additional Manufacturer Narrative
The insert, used in treatment, was returned and evaluated.The patella, used in treatment, was not returned for evaluation; therefore the failure mode could not be confirmed.A visual inspection of the returned device could not confirm the stated failure mode.The device had signs of damage from implantation.The device was manufactured in 2016 and exhibits signs of extensive wear.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-assessed.A dimensional inspection was attempted but the device was too damaged from implantation to obtain accurate measurements.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.Some potential probable causes of this event could include improper fit/sizing or laxity changes in the joint.Based on this investigation, the need for corrective action is not indicated.Should the patella or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JRNY II BCS CNSTRD ART ISRT RT 5-6 11M
• 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: 9359322
• Report Number: 1020279-2019-04131
• Device Sequence Number: 480192
• Product Code: JWH
• UDI-Device Identifier: 00885556174913
• UDI-Public: 00885556174913
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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 Model Number: 74029253
• Device Catalogue Number: 74029253
• Device Lot Number: 16CM20039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1