MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 29 MM STD; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74024829
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	11/08/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was having knee pain, redness and swelling, and an incision and drainage of the left knee with arthrocentesis was performed due to proximal leg abcess with secondary cellulitis adjacent to total knee arthroplasty.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, (b)(6) details regarding the patient¿s weight-bearing status, bone quality, and fall/trauma history have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported subluxation of tibial component is due to the anterior posterior instability which also was the reason for the revision.The patient¿s medical history is significant for multiple comorbidities which cannot be ruled out as possible contributing factors.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JRNY BCS PAT RESRF RD 29 MM STD
• 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: 8350754
• Report Number: 1020279-2019-00692
• Device Sequence Number: 14016477
• Product Code: JWH
• UDI-Device Identifier: 03596010554529
• UDI-Public: 03596010554529
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: 07/10/2020
• Device Catalogue Number: 74024829
• Device Lot Number: 10GM06523
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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: 69 YR