MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY TIB BPLT RT SZ 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71933635
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/16/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through retrospective study that patient underwent remedial therapy and other conservative approach due to popping of right knee.Severity was deemed mild.
Additional Manufacturer Narrative
Based on additional information received from the study site this event was re-determined and it was concluded that the reported complaint does not represent an event which requires reporting per cfr 21 part 803.For this reason we ask you to disregard report 1020279-2017-00489.

• Brand Name: JRNY TIB BPLT RT SZ 9
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6685602
• Report Number: 1020279-2017-00489
• Device Sequence Number: 162365
• Product Code: JWH
• UDI-Device Identifier: 00885556061718
• UDI-Public: 00885556061718
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2017

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: 71933635
• Device Catalogue Number: 71933635
• Device Lot Number: 08KM07946
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/16/2017; 07/31/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 07/17/2017; 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JRNY BCS PAT RESRF RD 41 MM STD, (B)(4) /UNK LOT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 123