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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 5 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 5 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-30-506
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Codes Pleural Effusion (2010); No Code Available (3191)
Date of Event 12/11/2019
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
It was reported that the patient has rotated his femur off the tibial polyethylene implant.He corrected it once with a poly revision but it has spun out again a month later.Doi: unknown.Dor: unknown; unknown affected side.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE CR RP INSRT SZ 5 6MM
Common Device Name
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key9943985
Report Number1818910-2020-10579
Device Sequence Number2208807
Product Code NJL
UDI-Device Identifier10603295047759
UDI-Public10603295047759
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/09/2019
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? Yes
Operator of Device Health Professional
Device Model Number1516-30-506
Device Catalogue Number151630506
Device Lot Number8508661
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/27/2020
Supplement Date Received by Manufacturer04/08/2021
Initial Report FDA Received Date04/09/2020
Supplement Report FDA Received Date04/11/2021
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 CR RP INSRT SZ 5 6MM; ATTUNE FEM POR CR RT SZ 5; ATTUNE RP TIB BASE SZ 6 POR; ATTUNE CR RP INSRT SZ 5 6MM; ATTUNE FEM POR CR RT SZ 5; ATTUNE RP TIB BASE SZ 6 POR
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
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