MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 12MM; PRSTHSIS,KNEE,PATLLFMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	74027244
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed in the patient due to increased laxity product of falling.A patellar component was implanted.The insert was explanted.
Additional Manufacturer Narrative
The associated journey ii bcs articular insert was not returned for evaluation.A clinical analysis noted that details regarding the patient¿s weight-bearing status, medical history, bone quality, and other additional clinical relevant information have not been provided.The root cause of the reported knee instability, increased laxity and pain cannot be concluded.However, the patient falls prior to the revision could not be ruled out as contributing factors to the reported event.The patient impact beyond the reported revision cannot be determined.No further clinical assessment is warranted at this time.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part 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 product failed to meet any product specifications at the time of manufacture.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 12MM
• Common Device Name: PRSTHSIS,KNEE,PATLLFMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7931209
• Report Number: 1020279-2018-02037
• Device Sequence Number: 16622993
• Product Code: JWH
• UDI-Device Identifier: 00885556177761
• UDI-Public: 00885556177761
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 01/28/2024
• Device Catalogue Number: 74027244
• Device Lot Number: 14AM23389
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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
• Patient Age: 49 YR