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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY CMW 9610921 UNKNOWN DEPUY GMV CEMENT CEMENT / CEMENT ACCESSORY

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DEPUY CMW 9610921 UNKNOWN DEPUY GMV CEMENT CEMENT / CEMENT ACCESSORY Back to Search Results
Catalog Number UNK-CEMENT/CEM ACCESORY
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Pain (1994)
Event Date 03/07/2017
Event Type  Injury  
Manufacturer Narrative
Follow-up with the complainant has been conducted for the catalog number and lot number and this information is unavailable. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Patient was revised to address pain and tibial loosening. Loosening occurred at the cement/implant interface. Cement manufactured by depuy.
 
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. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand NameUNKNOWN DEPUY GMV CEMENT
Type of DeviceCEMENT / 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 Key6409415
MDR Text Key70094411
Report Number1818910-2017-14782
Device Sequence Number1
Product Code JDY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-CEMENT/CEM ACCESORY
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2017
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 Treatment Data
Date Received: 03/16/2017 Patient Sequence Number: 1
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