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

Catalog Number 3122040

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 08/08/2013

Event Type  Injury  

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).

Event Description

Legal claim and medical records received.Patient was revised on (b)(6) 2013 for a painful malpositioned patella.The manufacturer of the cement removed is unknown.Part/lot not provided.Update 8/14/15, 8/24/15 & 8/26/15 medical records received.After review of the medical records for mdr reportability, there is no additional information that would affect the investigation.The complaint was updated on:9/8/2015.Update 9/28/15 and 10/12/2015: medical records received.After review of the medical records for mdr reportability, part/lot has been provided.The cement used on the primary was depuy so it now being reported for pain.The unknown depuy product is being changed to the patella the complaint was updated on:10/23/2015.

Manufacturer Narrative

No device associated with this report was received for examination.A complaint database search found additional reports for the smartset mv 40g eo.Review of the device history records in a previous investigation did not reveal any related manufacturing deviations or anomalies on the provided product and lot combination.A worldwide complaint database search found no other reported incident(s) against the remaining product/lot combination since release for distribution.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 the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SMARTSET MV 40G - 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: 5173879
• MDR Text Key: 29171644
• Report Number: 1818910-2015-33565
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK081155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Catalogue Number: 3122040
• Device Lot Number: 2972194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2009
• 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: 66 YR
• Patient Weight: 64