MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REV JOURNEY ART INS BCS STD 7-8 RT 10; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	71934537
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case- (b)(4).
Event or Problem Description
It was reported that the patient presented on (b)(6) 2020 with a dislocated tkr after crossing legs in a figure 4 position.Surgeon tried a closed reduction with no success so patient was booked for open reduction the next day.The old poly was removed and it was noticed that it was broken.A new journey revision insert was implanted.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: REV JOURNEY ART INS BCS STD 7-8 RT 10
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11027275
• Report Number: 1020279-2020-07554
• Device Sequence Number: 690564
• Product Code: JWH
• UDI-Device Identifier: 00885556182710
• UDI-Public: 885556182710
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 71934537
• Device Lot Number: 12FM03023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 08/31/2021
• 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: Required Intervention