MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	74027262
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a two step revision surgery was performed due to a peri-prosthetic joint infection in left knee.In first step of the revision surgery, on (b)(6) 2017, patellar component and articular insert were explanted and an antibiotic spacer was implanted.And on (b)(6) 2017 the total knee was revised to perform a reimplantation of devices.
Additional Manufacturer Narrative
The associated journey ii bcs oxinium femoral component, journey ii bcs articular insert and journey tibial baseplate and genesis ii resurfacing patellar were not returned for evaluation.Our investigation included a review of the manufacturing records for the listed batches which 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 failure mode with the same batch number.Products were sterilized according to sterilization release documentation from quality control.A clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment; therefore no medical assessment is warranted at this time.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM
• 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: 7891868
• Report Number: 1020279-2018-01853
• Device Sequence Number: 2725966
• Product Code: JWH
• UDI-Device Identifier: 00885556178010
• UDI-Public: 00885556178010
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: 12/09/2023
• Device Catalogue Number: 74027262
• Device Lot Number: 13MM08411
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 02/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR