MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 4; PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMERMETALPLYMER

Catalog Number	OR74022124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical procedure is scheduled for examination under anesthesic, arthroscopy and arthroscopic arthrolysis.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, this clinical study was re-opened due to the receipt of an ae #3 forms.However, neither the explant, nor clinical supporting documents have been provided for inclusion in this investigation.Therefore, no medical assessment can be performed.In the event relevant clinical/medical information is provided, this complaint will be reassessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 4
• Common Device Name: PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMERMETALPLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7561347
• Report Number: 1020279-2018-01019
• Device Sequence Number: 2221969
• Product Code: JWH
• UDI-Device Identifier: 00885556170366
• UDI-Public: 00885556170366
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

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 Catalogue Number: OR74022124
• Device Lot Number: 14HM14604
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR