MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 7; PROST, PATFEMTIB, SEM-CNSTRND, CMNTD, POLY/MET/POLY

Model Number	74021167
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	08/17/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a patient presented left knee soreness, pain and swelling.It was treated conservatively.The outcome of the patient is unknown.No additional information was provided at this time.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, per complaint details, the study patient presented with left knee soreness, pain and swelling which was "treated conservatively".However, responses to clinical documentation requests were not received by the date of this assessment.Based on the information provided, the root cause of the reported event could not be concluded and the patient outcome beyond the reported symptoms and the unspecified "conservative" treatment could not be determined.The current patient's status is unknown.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.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.

• Brand Name: JRNY II CR FEM OX NP LT SZ 7
• Common Device Name: PROST, PATFEMTIB, SEM-CNSTRND, CMNTD, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10932147
• Report Number: 1020279-2020-06896
• Device Sequence Number: 13670840
• Product Code: JWH
• UDI-Device Identifier: 00885556422762
• UDI-Public: 00885556422762
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/25/2021

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 Model Number: 74021167
• Device Catalogue Number: 74021167
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 06/27/2021
• 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: UNKN JOURNEY BCS / JOURNEY II BCS KNEE TIB BASEPLA; UNKN JOURNEY II CR KNEE TIB INSERT.; UNKN JOURNEY BCS / JOURNEY II BCS KNEE TIB BASEPLA; UNKN JOURNEY II CR KNEE TIB INSERT.
• Outcome Attributed to Adverse Event: Required Intervention