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
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery in which poly was retrieved due to it was showing signs of possible pitting.
Additional Manufacturer Narrative
Information received does not state when was the explantation date.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7845380
• Report Number: 1020279-2018-01694
• Device Sequence Number: 1535730
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 00885556033982
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2019
• Device Catalogue Number: 71453121
• Device Lot Number: 09LM05259
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 09/20/2018; 09/20/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 09/26/2018; 12/20/2018
• 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: Required Intervention
• Patient Weight: 120