MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM; PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	74027232
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/14/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an aspiration of the right knee was performed due to infection and inflammation reaction.
Event or Problem Description
It was reported that a revision surgery was performed due to infection.
Event or Problem Description
It was reported that a drainage of the knee was done and a liner exchange was performed due to infection.
Additional Manufacturer Narrative
The associated devices were not returned for evaluation.A review of quality documentation determined that all devices were sterilized per procedures.Based on the available information, the revision was performed as a result of the infection but the infection approximately two years after implantation to viridan¿s strep is most likely hematogenously spread, and not due to the implanted device.It is reported that as of (b)(6) 2017, the patient continues to see infection specialist.No further clinical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information or the device be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM
• Common Device Name: PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7205735
• Report Number: 1020279-2018-00062
• Device Sequence Number: 16397899
• Product Code: JWH
• UDI-Device Identifier: 00885556179062
• UDI-Public: 00885556179062
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2018

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: 10/22/2023
• Device Catalogue Number: 74027232
• Device Lot Number: 13KM18637
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 12/28/2017; 12/28/2017; 12/28/2017
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 01/29/2018; 04/23/2018; 05/23/2018
• 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: Other; Required Intervention
• Patient Age: 74 YR