MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 4MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71434304

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 10/16/2018

Event Type  Injury  

Event Description

It was reported that a patient presented with infected left total knee replacement and a revision surgery was performed for removal of implants and debridement of joint.

Manufacturer Narrative

D1, d2, d4, g4, g5, and h2 is new additional information that was received for this case.

Manufacturer Narrative

The associated 4mm offset couplers, pressfit stems, 5mm posterior femoral augment, 5 x 10mm l wedge femoral augment, 13mm 5-6 pshf tibial insert, left legion revision tibial baseplate size 5, left legion constrained femur, 10mm full wedge tibial augment size 5-6 and biconvex patella were not made available for evaluation.Therefore a product inspection could not be performed.Device details were not provided.Reasonable efforts to obtain the product information have not been successful.As device details were not made available, device history record and sterilization documentation review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch information.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual products involved and no product information available, our investigation of this report is inconclusive.Our clinical analysis noted that no relevant supporting clinical information has been provided.Therefore based on insufficient information, no further clinical assessment can be performed at this time.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: LGN OFFSET COUPLER TRIAL 4MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8066174
• MDR Text Key: 126992384
• Report Number: 1020279-2018-02456
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71434304
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 03/15/2019; 03/15/2019
• Supplement Dates FDA Received: 03/21/2019; 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR