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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 4 16MM; KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 4 16MM; KNEE TIBIAL INSERT Back to Search Results
Model Number 1517-10-416
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 08/18/2020
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 due to infected knee.Removal of implants was performed.Doi: (b)(6) 2020.Dor: (b)(6) 2020.Left 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
ATTUNE CRS RP INSRT SZ 4 16MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10507315
Report Number1818910-2020-19619
Device Sequence Number19581314
Product Code NJL
UDI-Device Identifier10603295055846
UDI-Public10603295055846
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
P830055
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) 08/18/2020
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 Number1517-10-416
Device Catalogue Number151710416
Device Lot Number8699998
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/18/2020
Supplement Date Received by Manufacturer10/16/2020
Initial Report FDA Received Date09/09/2020
Supplement Report FDA Received Date10/16/2020
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 LT SZ 4 CEM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN PRESSFIT STR STEM12X110MM; ATUN PRESSFIT STR STEM12X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE REV RP TIB BASE SZ 4 CEM; COMPETITOR CEMENT; ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN PRESSFIT STR STEM12X110MM; ATUN PRESSFIT STR STEM12X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE REV RP TIB BASE SZ 4 CEM; COMPETITOR CEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age62 YR
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