MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 6; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/MTL/PLYMR

Catalog Number	74022126
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/03/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a medical intervention was needed to perform a joint effusion of the left knee.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical group concluded, all medical documents provided as of this date have been reviewed and considered and unless noted, do not identify a root cause or contribute to the clinical investigation.Therefore based on insufficient relevant information, no further clinical assessment is warranted.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 II FEMORAL OXIN LT SZ 6
• Common Device Name: PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7313059
• Report Number: 1020279-2018-00263
• Device Sequence Number: 1476037
• Product Code: JWH
• UDI-Device Identifier: 00885556170465
• UDI-Public: 00885556170465
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 04/25/2022
• Device Catalogue Number: 74022126
• Device Lot Number: 12DM17032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 06/12/2018
• 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: Required Intervention
• Patient Age: 78 YR