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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 45MM FULL POR; KNEE FEMORAL ACCESSORY
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DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 45MM FULL POR; KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1511-01-205
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 08/03/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(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
The patient was revised to address infection.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 at this time.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
ATUN FEM SLV M/L 45MM FULL POR
Common Device Name
KNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10401803
Report Number1818910-2020-18052
Device Sequence Number3066122
Product Code JWH
UDI-Device Identifier10603295419594
UDI-Public10603295419594
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K160700
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/03/2020
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 Number1511-01-205
Device Catalogue Number151101205
Device Lot NumberHZ3946
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/03/2020
Supplement Date Received by Manufacturer09/25/2020
Initial Report FDA Received Date08/13/2020
Supplement Report FDA Received Date09/28/2020
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 6 CEM; ATTUNE CRS RP INSRT SZ 6 14MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE DIST FEM AUG SZ 6 8MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 4 CEM; ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 14MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE DIST FEM AUG SZ 6 8MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 4 CEM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age63 YR
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