MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R HA POROUS FEM SZ 5RT; GENESIS II TOTAL KNEE SYSTEM

Catalog Number 71422030

Device Problem Corroded (1131)

Patient Problem No Code Available (3191)

Event Date 03/19/2016

Event Type  Injury  

Manufacturer Narrative

Udi#: (b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported that the patient underwent a revision surgery due to product fretting and corrosion.

Manufacturer Narrative

Disregard; mdr 1020279-2016-00667 was filed in error.It is a duplicate of mdr 1020279-2016-00283.

• Brand Name: GII C/R HA POROUS FEM SZ 5RT
• Type of Device: GENESIS II TOTAL KNEE SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5903349
• MDR Text Key: 52965509
• Report Number: 1020279-2016-00667
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 71422030
• Device Lot Number: 11LM07863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR