MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY PF IMPLANT MED LT; PATELLO-FEMORAL REPLACEMENT

Catalog Number 71461014

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 12/28/2011

Event Type  Injury  

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported that the patient underwent a revision surgery 6 weeks post op after sustaining a fall.

Manufacturer Narrative

Additional information: (b)(4).No clinical supporting documents have been provided to conduct a through analysis of the reported device failure.No product was returned, hence visual or dimensional inspection could not be completed.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.If more information is received, this investigation will be reopened.

• Brand Name: JOURNEY PF IMPLANT MED LT
• Type of Device: PATELLO-FEMORAL REPLACEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 5029410
• MDR Text Key: 24010339
• Report Number: 1020279-2015-00602
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K051086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2019
• Device Catalogue Number: 71461014
• Device Lot Number: 09EM14423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR