MAUDE Adverse Event Report: DEPUY CMW 9610921 UNKNOWN DEPUY SMARTSET HV CEMENT; CEMENT / CEMENT ACCESSORY

Catalog Number UNK-CEMENT/CEM ACCESORY

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 12/04/2015

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.See report for any product information received.Depuy synthes has been informed that the catalog number and lot number is not available.

Event Description

Patient was revised to address pain and tibial loosening at the cement/implant interface.Depuy cement was used.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).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: UNKNOWN DEPUY SMARTSET HV CEMENT
• 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: 5285241
• MDR Text Key: 33243688
• Report Number: 1818910-2015-37165
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CEMENT/CEM ACCESORY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR