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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-125
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Stroke/CVA (1770)
Date of Event 06/22/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.This device was also subject of (b)(4) as the patient experienced adverse events on different days with the same device.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
Pc was created to capture the event during revision on (b)(6) 2020.During the revision surgery, the patient also sustained a stroke event that caused impaired short-term memory.Doe: (b)(6) 2020.
 
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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: dhr reviewed - no deviations or nonconformance's were noted.
 
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Brand Name
ATTUNE PS FEM LT SZ 5 NAR CEM
Common Device Name
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12218381
Report Number1818910-2021-15885
Device Sequence Number14468683
Product Code JWH
UDI-Device Identifier10603295041702
UDI-Public10603295041702
Combination Product (Y/N)N
Initial Reporter StateLA
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 other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/01/2021
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 Number1504-10-125
Device Catalogue Number150410125
Device Lot Number415871
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/01/2021
Supplement Date Received by Manufacturer08/17/2021
Initial Report FDA Received Date07/23/2021
Supplement Report FDA Received Date08/17/2021
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 FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM LT SZ 5 NAR CEM; STRYKER COMPETITOR PRODUCTS; UNK CEMENT GENTAMICIN; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM LT SZ 5 NAR CEM; STRYKER COMPETITOR PRODUCTS; UNK CEMENT GENTAMICIN
Outcome Attributed to Adverse Event Required Intervention;
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