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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FEM LT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND 9616671 ATTUNE CR FEM LT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Catalog Number 150400109
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Not Applicable (3189)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient was revised due to continued pain.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary:no device associated with this report was received for examination.Device history lot: null device history batch: null device history review: null if information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
 
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Brand Name
ATTUNE CR FEM LT SZ 9 CEM
Type of Device
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy
cork
EI  
Manufacturer Contact
chad gibson
700 orthopaedic dr.
warsaw, IN 46582
5743725905
MDR Report Key7621017
MDR Text Key111736548
Report Number1818910-2018-62744
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295041108
UDI-Public10603295041108
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 05/29/2018
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 Catalogue Number150400109
Device Lot Number8033767
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/29/2018
Initial Date FDA Received06/20/2018
Supplement Dates Manufacturer Received07/23/2018
Supplement Dates FDA Received08/13/2018
Date Device Manufactured12/08/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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