MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 8; PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCEMENTEDPOLYMERMETALPOLYMER

Model Number	74022118
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an arthroscopy was performed due to arthrofibrosis.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that this complaint is from the journey ii bcs study, reporting a revision secondary to ¿arthrofibrosis¿.It has been communicated that no further information would be forthcoming.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include a surgical complication or procedural error.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 complaints will be reopened.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 8
• Common Device Name: PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCEMENTEDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9482463
• Report Number: 1020279-2019-04439
• Device Sequence Number: 13527309
• Product Code: JWH
• UDI-Device Identifier: 00885556170069
• UDI-Public: 00885556170069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• 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): 03/16/2020

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: 05/18/2026
• Device Model Number: 74022118
• Device Catalogue Number: 74022118
• Device Lot Number: 16EM16274
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 03/16/2020
• 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