MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422261

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/28/2019

Event Type  Injury  

Event Description

It was reported a revision surgery due to a poly switch of an acute infection 2 weeks postoperative.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.Scratches and wear were observed on the proximal, distal, and outer surfaces.Some deformation was also observed, mainly on the locking detail.The device was manufactured in 2017 and exhibits signs of wear.The lab analysis concluded that the root cause of the reported infection cannot be confirmed from this analysis.No material or manufacturing deviations were observed in the process of this investigation.The medical investigation concluded that, per complaint details, the revision/poly exchange was performed 2 weeks post implantation due to an acute post-operative infection, although the root cause of the infection is unknown.It was communicated that no further clinically relevant documentation will be provided.The patient impact beyond the reported revision secondary to an acute infection cannot be determined.Should the product evaluation/lab retrieval analysis provide insight into the reported acute post-operative infection, the assessment may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Should additional information be received, the complaint will be reopened and reevaluated.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/RL8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 8712937
• MDR Text Key: 148446615
• Report Number: 1020279-2019-02333
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582201
• UDI-Public: 03596010582201
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71422261
• Device Lot Number: 17LM05557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• 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: 83 YR
• Patient Weight: 78