MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71453121

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2018

Event Type  Injury  

Event Description

It was reported a revision surgery in which poly was retrieved due to it was showing signs of possible pitting.

Manufacturer Narrative

Information received does not state when was the explantation date.

Manufacturer Narrative

The associated device was returned and evaluated.The component was inspected visually to determine the cause of the reported dissociation.No destructive analysis was conducted during this investigation.Damage/deformation was observed on the superior surface of the insert.These features were likely created by third-body particulate (bone chips, bone cement, etc).Similar features have been previously observed on inserts retrieved due to loosening.The non-articulating surface has some scratches and deformation.The insertion/extraction slot is deformed, likely due to insertion and removal.A clinical evaluation was conducted and the intraoperative findings of significant gout crystals and approximately 3 large, loose cement particles were most likely the contributing factors to the reported pain, resultant insert pitting and the synovitis/major synovectomy.The continued ligament laxity was most likely the contributing factor to the reported return of left knee pain, instability, and subsequent insert revision/poly exchange, as the surgeon was reportedly pleased with the outcome of the procedure/increased poly thickness.Although no additional impact is anticipated, the patient impact beyond the reported symptoms, left knee synovectomy, 3rd body debris removal, insert revision and an expected post-op convalescence period cannot be determined.No further medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.We will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 5-6 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7845380
• MDR Text Key: 119154184
• Report Number: 1020279-2018-01694
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 00885556033982
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2019
• Device Catalogue Number: 71453121
• Device Lot Number: 09LM05259
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 09/20/2018; 09/20/2018
• Supplement Dates FDA Received: 09/26/2018; 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 120