MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	71453122
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was admitted for mechanical failure of internal joint prosthesis, left knee.Patient was taken to surgery on (b)(6) 2017 for revision of left total knee arthroplasty, synovectomy and debridement.Per operative note, the previous 11 mm thick polyethylene insert demonstrated lateral sided wear and examination under anesthesia intra-operatively demonstrated instability.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see the attached files for the results of our investigation.(b)(4).

• Brand Name: LGN CR HIGH FLEX XLPE SZ 5-6 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6518440
• Report Number: 1020279-2017-00294
• Device Sequence Number: 781523
• Product Code: JWH
• UDI-Device Identifier: 00885556035139
• UDI-Public: 00885556035139
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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: 03/23/2023
• Device Catalogue Number: 71453122
• Device Lot Number: 13CM15004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR