MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 38 MM STD; PRSTHSIS,KN,PATLLFMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMER

Catalog Number	74024838
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a right knee effusion was performed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, this is a complaint from the (b)(6) study reporting a right knee effusion, approximately 6 months post implantation.Several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.The prosthesis remains implanted at this time.Should information become available this complaint can be re-assessed.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 parts revealed no prior complaints for the listed batches.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.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 38 MM STD
• Common Device Name: PRSTHSIS,KN,PATLLFMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7714977
• Report Number: 1020279-2018-01377
• Device Sequence Number: 19112648
• Product Code: JWH
• UDI-Device Identifier: 03596010554550
• UDI-Public: 03596010554550
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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: 03/29/2026
• Device Catalogue Number: 74024838
• Device Lot Number: 16CM21979
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 11/14/2018
• 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: 60 YR