MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S7-8 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421547
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/05/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had impinging scar tissue and effusion with some synovitis.It was resolved through an arthroscopy of left knee replacement with debridement of a synovial fold and scar tissue in the medial gutter.
Additional Manufacturer Narrative
It was reported that patient had iminging scar tissue and it was resolved with an unspecified procedure.The affected genesis ii resurfacing patella, genesis ii cr deep flexion insert, genesis ii non-porous tibial baseplate and legion oxinium femoral component, used intreatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual products involved and no patient medical records available, no root cause can be determined.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaint will be reopened.Smith and nephew will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GII CR DEEP FLEX ISRT S7-8 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9050708
• Report Number: 1020279-2019-03357
• Device Sequence Number: 16590489
• Product Code: JWH
• UDI-Device Identifier: 03596010512505
• UDI-Public: 03596010512505
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2020

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: 11/04/2022
• Device Catalogue Number: 71421547
• Device Lot Number: 12LM03070
• Initial Date Received by Manufacturer: 11/05/2013
• Supplement Date Received by Manufacturer: 08/15/2019; 01/10/2020
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 09/16/2019; 01/14/2020
• 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