MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 4; PRSTHSIS,KNEE,PATLLOFEMROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMER/METAL/POLYMR

Catalog Number	74022124
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/28/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to a mechanical complication of prosthetic joint.
Additional Manufacturer Narrative
The associated complaint devices were not returned to be evaluated.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical/medical investigation stated that with no supporting clinical/medical documents have been provided.Therefore a thorough investigation cannot be performed.Without the actual products involved, our investigation cannot proceed.If the devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 4
• Common Device Name: PRSTHSIS,KNEE,PATLLOFEMROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMER/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7520550
• Report Number: 1020279-2018-00947
• Device Sequence Number: 16570058
• Product Code: JWH
• UDI-Device Identifier: 00885556170366
• UDI-Public: 00885556170366
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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: 04/08/2023
• Device Catalogue Number: 74022124
• Device Lot Number: 13DM07889
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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: 67 YR