MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 11MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	74027243
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that journey ii bcs inserts were changed due to infection of both knees.Primary surgery was performed on (b)(6) 2019.
Additional Manufacturer Narrative
The devices, intended for use in treatment, were not returned for evaluation.A visual inspection of the device could not be performed.A relationship between the device and the reported event could not be corroborated.There is no information to suggest the device failed to meet specifications.A clinical evaluation was conducted and no clinically relevant supporting documentation was provided, therefore, a thorough medical investigation could not be performed.However, per complaint details, the insert revisions were performed due to bilateral knee infections.The patient impact beyond the reported insert revisions cannot be concluded.Should clinical documentation become available in the future, the clinical/medical investigation task may be re-opened.No further medical assessment is warranted at this time.No probable cause could be identified with the limited information provided.Infection is a risk associated with any surgical procedure.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.A dhr could not be performed due batch numbers no provided.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 11MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8920254
• Report Number: 1020279-2019-03112
• Device Sequence Number: 11399916
• Product Code: JWH
• UDI-Device Identifier: 00885556177716
• UDI-Public: 00885556177716
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K11711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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 Catalogue Number: 74027243
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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: Required Intervention