MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 6; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74022116
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an aspiration performed due to continued pain and swelling at the right knee.
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 it was reported an aspiration was performed due to continued pain and swelling.The office visit did indicate the patient suffered from right knee pain/ swelling ¿since r tka¿ 2 years ago for which a ¿re-aspirate his knee and inject cortisone as a diagnostic and therapeutic tool¿ was performed.No reports were provided in the medical records; therefore, a root cause of the aspiration could not be concluded.A second opinion documented the patient had an extensive work-up history for infection and loosening ¿which have all been shown to be negative¿ and ¿currently i do not believe that the lateral patellar osteophyte is causing his symptoms¿.Without supporting medical documentation, the patient impact beyond the reported ¿relentless pain¿ and aspiration followed by injection could not be concluded.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Pain and swelling are potential complications associated with any surgery.Some potential probable causes of this event could include patient reaction or a post-operative healing issue.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.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 6
• 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: 9349478
• Report Number: 1020279-2019-04092
• Device Sequence Number: 296568
• Product Code: JWH
• UDI-Device Identifier: 00885556169964
• UDI-Public: 00885556169964
• Combination Product (Y/N): N
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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 Model Number: 74022116
• Device Catalogue Number: 74022116
• Device Lot Number: 16KM13615
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 03/09/2020
• 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
• Patient Age: 41 YR