MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR HI FLEX XLPE ISRT 7-8 10MM; CROSSLINKED POLYETHYLENE ARTICULAR INSERTS

Catalog Number	71453187
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon reports patient was professing well.0 to 110 degrees.Walking with stick.Physiotherapist pushed hard on knee and patient felt pain and became stiff.Surgeon believes that the knee being bent excessively led to a stitch pooping and fluid getting into the joint.This resulted in stiffness and pain with bending.Revision - (b)(6) 2018.Surgeon opened the knee, debrided any scar tissue.Rom - 5 to 70 degrees.Washout the joint out.Downsized to 9mm poly - see usage; no xray; no report for surgeon or hospital; no return of implant; surgeon does not fault the implant; general health- good; patient was compliant.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical group concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: LEGION CR HI FLEX XLPE ISRT 7-8 10MM
• Common Device Name: CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7471704
• Report Number: 1020279-2018-00832
• Device Sequence Number: 11070965
• Product Code: MBH
• UDI-Device Identifier: 00885556487549
• UDI-Public: 00885556487549
• Combination Product (Y/N): N
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: No Information
• Device Catalogue Number: 71453187
• Device Lot Number: 16JM14174
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 06/13/2018
• 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: Hospitalization