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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY CMW ¿ 9610921 ATTUNE CR RP INSRT SZ 7 6MM; KNEE TIBIAL BEARING/INSERT
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DEPUY CMW ¿ 9610921 ATTUNE CR RP INSRT SZ 7 6MM; KNEE TIBIAL BEARING/INSERT Back to Search Results
Catalog Number 151630706
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 09/28/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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
Patient was revised to address pain.
 
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ATTUNE CR RP INSRT SZ 7 6MM
Common Device Name
KNEE TIBIAL BEARING/INSERT
Manufacturer (Section D)
DEPUY CMW ¿ 9610921
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key7003060
Report Number1818910-2017-27627
Device Sequence Number13739456
Product Code NJL
UDI-Device Identifier10603295047995
UDI-Public10603295047995
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 09/28/2017
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 Catalogue Number151630706
Device Lot Number8204786
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/28/2017
Supplement Date Received by Manufacturer11/08/2017
Initial Report FDA Received Date11/06/2017
Supplement Report FDA Received Date11/20/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age59 YR
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