MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	71453211
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a literature review a traumatic late dissociation of the polyethylene insert with the patellar tendon rupture after the tka.2 years after the primary surgery, the patient complained of sudden onset knee pain with restricted motion after fall at home.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Our clinical/medical team noted no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.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.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 9MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7993353
• Report Number: 1020279-2018-02240
• Device Sequence Number: 19310462
• Product Code: JWH
• UDI-Device Identifier: 03596010492388
• UDI-Public: 03596010492388
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2018

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: 01/19/2025
• Device Catalogue Number: 71453211
• Device Lot Number: 15AM13868
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018; 09/26/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/04/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4) ; (B)(4)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR