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
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery needed to be performed due to the legion insert being disassociated from the baseplate.
Additional 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 or Problem Description
As updated by customer, patient is not willing to have the revision surgery.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2018-00260
• Device Sequence Number: 2273473
• Product Code: JWH
• UDI-Device Identifier: 00885556034804
• UDI-Public: 00885556034804
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2024
• Device Catalogue Number: 71453203
• Device Lot Number: 14GT44223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 02/19/2018; 10/28/2018
• Initial Report FDA Received Date: 03/03/2018
• Supplement Report FDA Received Date: 04/17/2018; 11/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention