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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 8 4MM; KNEE FEMORAL ACCESSORY
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DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 8 4MM; KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1549-08-001
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Bone Fracture(s) (1870); No Code Available (3191)
Date of Event 09/25/2020
Type of Reportable Event Serious Injury
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
Clinical adverse event received for distal femur bone fracture, right event is serious and is considered mild.Event is definitely related to device and is probably related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (right knee).Treatment: open reduction internal fixation.
 
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.
 
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Brand Name
ATTUNE POS FEM AUG SZ 8 4MM
Common Device Name
KNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10711489
Report Number1818910-2020-22938
Device Sequence Number3933613
Product Code JWH
UDI-Device Identifier10603295383123
UDI-Public10603295383123
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K160700
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 health professional,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/06/2020
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 Number1549-08-001
Device Catalogue Number154908001
Device Lot NumberJ82X54
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/06/2020
Supplement Date Received by Manufacturer11/20/2020
Initial Report FDA Received Date10/21/2020
Supplement Report FDA Received Date11/24/2020
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 CRS FEMORAL RT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 16MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 8 4MM; ATUN FEM SLV M/L 50MM HALF POR; ATUN TIB SLV M/L 53MM FULL POR; ATUNE REV RP TIB BASE SZ 8 CEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 16MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 8 4MM; ATUN FEM SLV M/L 50MM HALF POR; ATUN TIB SLV M/L 53MM FULL POR; ATUNE REV RP TIB BASE SZ 8 CEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
Patient Weight125
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