MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 5; PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL

Model Number	74021155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	09/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient who underwent to a tka, suffered from right lower extremity cellulitis which was treated and resolved with cephalexin medication.This event is being reported because the aemb believes that the contribution of smith+nephew device to the serious injury experienced by a clinical trial subject cannot be excluded.
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, a patient developed rle cellulitis approximately 5 weeks post implantation.However, no responses to clinical documentation requests were received.The root cause could not be definitively concluded.Based on the limited information provided, the patient impact beyond the reported cellulitis and antibiotic therapy could not be determined, although reportedly the event was resolved.No further medical assessment can be rendered at this time.Should additional clinically relevant documentation/information become available, the medical investigation 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.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and 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.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 RT SZ 5
• Common Device Name: PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10591576
• Report Number: 1020279-2020-04903
• Device Sequence Number: 11365163
• Product Code: JWH
• UDI-Device Identifier: 00885556422847
• UDI-Public: 00885556422847
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: Lay User/Patient
• Device Model Number: 74021155
• Device Catalogue Number: 74021155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 07/01/2021
• 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: 71420570/GNS II BICONVEX PAT 29MM; 74022214/JOURNEY TIBIA BASE NP RT SZ 4; 74025631/JRNY II CR ISRT XLPE RT SZ 3-4 9MM; 71420570/GNS II BICONVEX PAT 29MM; 74022214/JOURNEY TIBIA BASE NP RT SZ 4; 74025631/JRNY II CR ISRT XLPE RT SZ 3-4 9MM
• Outcome Attributed to Adverse Event: Other; Required Intervention