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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DELTA CER HEAD 12/14 36MM +8.5; HIP FEMORAL HEAD
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DEPUY IRELAND 9616671 DELTA CER HEAD 12/14 36MM +8.5; HIP FEMORAL HEAD Back to Search Results
Catalog Number 136536330
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Foreign Body Reaction (1868)
Event Date 07/18/2014
Event Type  Injury  
Event Description
Patient was revised to address altr.
 
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
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 11/06/2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.There is no new information to report at this time.The complaint was updated on: 11/24/2014.
 
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.Corrective action was not indicated.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 Name
DELTA CER HEAD 12/14 36MM +8.5
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork, munster
EI 
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork, munster
EI  
Manufacturer Contact
steve dowell
700 orthopaedic drive
warsaw, IN 46581
5743714918
MDR Report Key4248775
MDR Text Key4986464
Report Number1818910-2014-31712
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP070026
Number of Events Reported1
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
Report Date 11/06/2014
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 Date10/31/2018
Device Catalogue Number136536330
Device Lot Number7810237
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/06/2014
Initial Date FDA Received11/13/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/24/2014
11/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient Weight75
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