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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 8 8MM KNEE FEMORAL ACCESSORY

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DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 8 8MM KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1547-08-002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)
Event Date 05/16/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Clinical adverse event received for post-operative anemia. Event is not serious and is considered mild. Event is definitely not related to device and is definitely related to procedure.

 
Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Clinical database information received. Patient reports pain, problems walking and doing usual activities and discomfort.

 
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Brand NameATTUNE DIST FEM AUG SZ 8 8MM
Type of DeviceKNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9450923
MDR Text Key184809729
Report Number1818910-2019-122294
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberK160700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup,Followup
Report Date 11/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1547-08-002
Device Catalogue Number154708002
Device LOT NumberHX2958
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/25/2018
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: 12/11/2019 Patient Sequence Number: 1
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