MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY PFJ IMPLANT X-SM LT; PATELLO-FEMORAL REPLACEMENT

Catalog Number 71461010

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision surgery was performed due to pain and a clicking patella.

Manufacturer Narrative

(b)(4).One journey knee implant (71461010) was received for investigation.The implant displays indent and/or scratch marks typical from the extraction procedure.A significant amount of cement and remaining trabecular structures are visible on the inferior side of the implant.The patellar implant was not returned.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.An evaluation performed by our research lab noted some signs of damage on the periphery of the proximal end of the articulating surface of the implant, which may have been caused during revision.Some burnishing was also visible on the edges of the implant.Cement was well adhered to the non-articulating surface and interdigitated with the host bone.Some cement was lifting off the implant at one end, which may have been caused during revision.Some cement was hanging over the edge of the implant, which may have contributed to pain.The primary source of the reported clicking and pain could not be determined from this analysis.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY PFJ IMPLANT X-SM 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: 5011163
• MDR Text Key: 23335894
• Report Number: 1020279-2015-00582
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2017
• Device Catalogue Number: 71461010
• Device Lot Number: 07CM02184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2007
• 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: 73 YR