MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 11MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMENTD,POLYMR/METAL/POLYMR

Catalog Number	74027273
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to patient dislocated prosthesis.
Additional Manufacturer Narrative
The affected journey ii bcs articular insert was not returned for evaluation.Our investigation included a review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number.Our clinical evaluation indicated that there was no clinically supportive documentation provided for inclusion in this medical investigation.Based on the lack of clinical information, the root cause of the dislocation cannot be concluded.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 RT 11MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMENTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7307525
• Report Number: 1020279-2018-00257
• Device Sequence Number: 1276609
• Product Code: JWH
• UDI-Device Identifier: 00885556179819
• UDI-Public: 00885556179819
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: 04/20/2023
• Device Catalogue Number: 74027273
• Device Lot Number: 13DM15343
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 05/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention