MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II ART ISRT TRL SZ 5-6 9MM LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74035261
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tka the poly broke on medial concave side.No delay or injury reported.A back up device was available.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.A small section of both devices fractured off and was returned.The devices had numerous nicks and gouges on the surface, particularly around the fracture site.The devices were manufactured in 2013 and 2015 and exhibit signs of extensive wear/usage.A review of complaint history did not reveal additional complaints for the listed batches for the same failure mode.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.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should 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 BCS II ART ISRT TRL SZ 5-6 9MM 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: 8497550
• Report Number: 1020279-2019-01485
• Device Sequence Number: 2675347
• Product Code: JWH
• UDI-Device Identifier: 00885556157039
• UDI-Public: 00885556157039
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• 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): 05/23/2019

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: 74035261
• Device Lot Number: 15FAP8129
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1