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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 3 8MM; KNEE FEMORAL ACCESSORY
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DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 3 8MM; KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1549-03-002
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/19/2021
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
Compass (b)(4) report: the patient was revised due to pain.The physician revised femur components to crs with stem.Doi: (b)(6) 2017, dor: (b)(6) 2021: left knee.
 
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Brand Name
ATTUNE POS FEM AUG SZ 3 8MM
Common Device Name
KNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12487177
Report Number1818910-2021-20357
Device Sequence Number19670572
Product Code JWH
UDI-Device Identifier10603295383024
UDI-Public10603295383024
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
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) 03/19/2021
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 Number1549-03-002
Device Catalogue Number154903002
Device Lot NumberJ28W39
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/19/2021
Supplement Date Received by Manufacturer09/20/2021
Initial Report FDA Received Date09/17/2021
Supplement Report FDA Received Date09/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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