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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS RT SZ 6 ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE FEM POR PS RT SZ 6 ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL Back to Search Results
Model Number 1504-11-206
Device Problems Noise, Audible (3273); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Edema (1820); Pain (1994); No Code Available (3191)
Event Date 10/09/2019
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary ==> the device associated with the reported event was not returned to the investigation site for evaluation. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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 NameATTUNE FEM POR PS RT SZ 6
Type of DeviceATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 46581-0988
6107428552
MDR Report Key9397420
MDR Text Key184389843
Report Number1818910-2019-119108
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK140881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,STUDY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/02/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1504-11-206
Device Catalogue Number150411206
Device LOT Number8897215
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 Received02/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/30/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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