MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY PF IMPLANT MED RT; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71461015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed for a replacement of the partial endoprosthesis due to a progression of osteoarthritis in the right knee.It was discovered the component was broken.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event has already been reported on mdr 1020279-2018-02782, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Additional Manufacturer Narrative
Further evaluation of this complaint determined that this record is a duplicate of an event that was previously reported to fda.The event in this report is being addressed under internal reference number (b)(4), which has been reported on mdr 1020279-2018-02782.Initial report for record (b)(4) was sent to fda on thu (b)(6) 2018.No further investigation warranted for this complaint.

• Brand Name: JOURNEY PF IMPLANT MED RT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8172067
• Report Number: 1020279-2018-02816
• Device Sequence Number: 11114385
• Product Code: KRR
• UDI-Device Identifier: 03596010544223
• UDI-Public: 03596010544223
• Combination Product (Y/N): N
• PMA/510(K) Number: K051086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2019

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: 03/14/2020
• Device Catalogue Number: 71461015
• Device Lot Number: 10CM10660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/27/2019; 01/27/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/31/2019; 05/26/2019
• 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: Hospitalization; Required Intervention