MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 10MM; PROSTHSIS,KNEE,PATLLOFEMROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	74025622
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a subject acquired instability of left tka.Subject was placed in brace in (b)(6) 2018; determination made in (b)(6) 2018 to revise insert.
Additional Manufacturer Narrative
The associated journey ii cr insert was not returned for evaluation.A clinical evaluation noted that thorough medical assessment cannot be performed based on the limited information provided in the case report forms.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY II CR ISRT XLPE LT SZ 1-2 10MM
• Common Device Name: PROSTHSIS,KNEE,PATLLOFEMROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7799483
• Report Number: 1020279-2018-01546
• Device Sequence Number: 14007828
• Product Code: JWH
• UDI-Device Identifier: 00885556422663
• UDI-Public: 00885556422663
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

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: 05/16/2024
• Device Catalogue Number: 74025622
• Device Lot Number: 14EM14737
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 11/22/2018
• 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: 71420576/15KM10201; 74021163/15JM10438; 74022222/15MM01699
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR