MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 4; PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR

Model Number	74022124
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one year after primary surgery, revision surgery had to be performed due to dislocation.The journey ii bcs femoral oxonium left size 4 was exchanged.Dr.Stated that the devices were not defective.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 4
• Common Device Name: PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9956439
• Report Number: 1020279-2020-01293
• Device Sequence Number: 14155316
• Product Code: JWH
• UDI-Device Identifier: 00885556170366
• UDI-Public: 00885556170366
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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 Model Number: 74022124
• Device Catalogue Number: 74022124
• Device Lot Number: UNKNOWN/UNREADABLE
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR