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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS LT SZ 6; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE FEM POR PS LT SZ 6; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL Back to Search Results
Model Number 1504-11-106
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/07/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that the doctor's last 3 attune pressfit femurs have been very difficult to implant/seat.
 
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Brand Name
ATTUNE FEM POR PS LT SZ 6
Common Device Name
ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12235105
Report Number1818910-2021-16186
Device Sequence Number14372854
Product Code MBH
UDI-Device Identifier10603295041917
UDI-Public10603295041917
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1504-11-106
Device Catalogue Number150411106
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/07/2021
Supplement Date Received by Manufacturer08/05/2021
Initial Report FDA Received Date07/27/2021
Supplement Report FDA Received Date08/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ATTUNE FEM POR PS LT SZ 6; UNKNOWN BONE CEMENT; ATTUNE FEM POR PS LT SZ 6; UNKNOWN BONE CEMENT
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