MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74027281
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a journey bcs case done with navio system, upon closing the patient, range of motion test was run and a clicking sound was heard.Doctor reopened the patient and tried to correct issue with no success.Cause of the sound is still unknown.
Additional Manufacturer Narrative
The associated journey bcs articular insert, journey tibia base and journey ii bcs oxinium femoral component were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.The manufacturing records and complaint history review was conducted.The review of the manufacturing records for the insert and the femoral component did not reveal any deviation from the standard manufacturing processes.The lot is unknown for the tibia base.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
The associated journey bcs articular insert, journey tibia base and journey ii bcs oxinium femoral component were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.The manufacturing records and complaint history review was conducted.The review of the manufacturing records for the insert and the femoral component did not reveal any deviation from the standard manufacturing processes.The lot is unknown for the tibia base.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM
• 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: 8704305
• Report Number: 1020279-2019-02299
• Device Sequence Number: 11260639
• Product Code: JWH
• UDI-Device Identifier: 00885556178317
• UDI-Public: 00885556178317
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/19/2019

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 Expiration Date: 09/24/2026
• Device Catalogue Number: 74027281
• Device Lot Number: 16JM14000
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019; 05/23/2019; 05/23/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 09/18/2019; 09/19/2019; 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER 74022128 / LOT NUMBER 18CM15633; PART NUMBER 74022227 / LOT NUMBER 19BM00592; PART NUMBER 74022227 / LOT NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention