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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR RP INSRT SZ 9 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT
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DEPUY IRELAND 9616671 ATTUNE CR RP INSRT SZ 9 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 151630906
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes Pain (1994); Not Applicable (3189)
Date of Event 09/13/2018
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
Patient was revised to address pain and loosening of the tibia component at the cement to implant interface.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Device history lot if information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
 
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Brand Name
ATTUNE CR RP INSRT SZ 9 6MM
Common Device Name
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key7940334
Report Number1818910-2018-71563
Device Sequence Number11247012
Product Code NJL
UDI-Device Identifier10603295048237
UDI-Public10603295048237
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/13/2018
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 Number151630906
Device Lot Number8145246
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/13/2018
Supplement Date Received by Manufacturer11/02/2018
Initial Report FDA Received Date10/05/2018
Supplement Report FDA Received Date11/02/2018
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 Age54 YR
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