MAUDE Adverse Event Report: DEPUY CMW SMARTSET GMV 40G US EO; CEMENT / CEMENT ACCESSORY

Catalog Number 545050501

Device Problem Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 08/19/2013

Event Type  Injury  

Event Description

Patient was revised to address tibial tray loosening at the cement/implant interface.The cement manufacturer at the original time of implantation is unknown.Update rec'd (b)(6) 2014 - patient's medical records were received.Records indicate the patient had depuy cement at the time of original implant.The cement is being added to the complaint.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Examination of the components revealed no fracture or other observed deficiency in the material of the components.Pitting of the tibial insert indicates that third body wear may have occurred.The lateralization of the patella, localized wear of the patellar bearing, and deformation of the tibial insert suggest that there may have been instability in the knee, resulting in unexpected stresses on the components, potentially resulting in loosening and pain.The bone growth around the patella may also have contributed to the pain the patient experienced.No evidence was found suggesting product error was a contributing factor and the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY CMW; cornford rd; blackpool FY4 4QQ; UK FY4 4QQ
• Manufacturer (Section G): 9610921 DEPUY CMW; cornford rd; blackpool FY4 4QQ; UK FY4 4QQ
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3599179
• MDR Text Key: 4166093
• Report Number: 1818910-2014-11836
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 545050501
• Device Lot Number: 2718333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 01/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2009
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 116