MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II CONST ISRT TRL S3-4 11MM RT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74034234
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial cracked during the case.No injuries or delays reported.No pieces left into the patient.Backup device available and used.No more information provided.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY BCS II CONST ISRT TRL S3-4 11MM RT
• 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: 8683943
• Report Number: 1020279-2019-02257
• Device Sequence Number: 11329937
• Product Code: JWH
• UDI-Device Identifier: 00885556002995
• UDI-Public: 00885556002995
• 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): 10/07/2019

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: 74034234
• Device Lot Number: 13FBG0146
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1