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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 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE FEM POR PS RT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL Back to Search Results
Model Number 1504-11-207
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 12/16/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Clinical code: appropriate term / code not available (e2402) utilized to capture infections (e19).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
The patient was revised to address infection and loosening of the unknown component at the bone to implant interface.Doi: (b)(6) 2020, dor: (b)(6) 2020, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed corrected.
 
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Brand Name
ATTUNE FEM POR PS RT SZ 7
Common Device Name
ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11117511
Report Number1818910-2021-00231
Device Sequence Number17124196
Product Code JWH
UDI-Device Identifier10603295042068
UDI-Public10603295042068
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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) 12/16/2020
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
Operator of Device Health Professional
Device Model Number1504-11-207
Device Catalogue Number150411207
Device Lot Number9574093
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/16/2020
Supplement Date Received by Manufacturer01/28/2021
Initial Report FDA Received Date01/05/2021
Supplement Report FDA Received Date01/29/2021
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 MEDIAL DOME PAT 41MM; ATTUNE PS RP INSRT SZ7 5MM; ATTUNE RP TIB BASE SZ 8 POR; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS RP INSRT SZ7 5MM; ATTUNE RP TIB BASE SZ 8 POR
Outcome Attributed to Adverse Event Required Intervention;
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