MAUDE Adverse Event Report: DEPUY CMW 9610921 SMARTSET GMV 40G US EO; CEMENT / CEMENT ACCESSORY

Catalog Number 545050501

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); No Information (3190)

Event Date 11/04/2014

Event Type  Injury  

Event Description

Patient was revised to address tibial subsidence and loosening at both interfaces.Depuy cement was used.

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.(b)(4).

Manufacturer Narrative

(b)(4).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.

Event Description

Update rec'd 12/11/2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.Records indicate the patient was revised to address pain as well.There is no new information that would change the existing mdr decision.The complaint was updated on: 01/06/2015.

Manufacturer Narrative

No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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.

Manufacturer Narrative

No device associated with this report was received for examination.A complaint database search on the provided smartset gmv 40g us eo (product code (b)(4), lot number 2946627) found additional reports.A previous dhr review was conducted (b)(4)) and did not reveal any related manufacturing deviations or anomalies.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should the 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 9610921; cornford rd; blackpool, lancashire FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW 9610921; cornford rd; blackpool, lancashire FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 4289820
• MDR Text Key: 5274621
• Report Number: 1818910-2014-32988
• 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,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/10/2014

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 Expiration Date: 06/30/2011
• Device Catalogue Number: 545050501
• Device Lot Number: 2946627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/07/2015; 02/03/2015; 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2009
• 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: 68 YR