MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 13MM; PROSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number 71453203

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 02/19/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery needed to be performed due to the legion insert being disassociated from the baseplate.

Manufacturer Narrative

The associated complaint device was not returned.A clinical analysis indicates based on the available information and the product analysis, the exact root cause of the insert disassociation/instability cannot be concluded.Should any relevant clinical/medical information become available this complaint can be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

Event Description

As updated by customer, patient is not willing to have the revision surgery.

Manufacturer Narrative

The associated legion ps high flexion insert and genesis ii tibial baseplate were returned and evaluated.A lab analysis conducted during this investigation noted that burnishing and scratches on the tibia baseplate and insert where they meet are likely caused by repeated motion between them.The locking mechanism on the insert is deformed, likely due to removal.The exact cause of dislocation could not be determined, based on the results of this investigation.A dimensional evaluation was attempted on the insert; the damage/deformation at several features of the poly insert would not allow for accurate measurement.The tibia baseplate measures to be within specification.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 13MM
• Type of Device: PROSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7312255
• MDR Text Key: 101459488
• Report Number: 1020279-2018-00260
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556034804
• UDI-Public: 00885556034804
• Combination Product (y/n): N
• PMA/PMN Number: K071071
• 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: 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71453203
• Device Lot Number: 14GT44223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Date Manufacturer Received: 10/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention