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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 8 CEM; ATTUNE KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 8 CEM; ATTUNE KNEE FEMORAL Back to Search Results
Model Number 1504-00-108
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Joint Laxity (4526)
Event Date 12/13/2021
Event Type  Injury  
Event Description
Clinical notification received for revision for instability.Date of implantation: (b)(6) 2021.Date of revision: (b)(6) 2021.Left knee.Treatment: revision of tibial insert.
 
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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 FEM LT SZ 8 CEM
Type of Device
ATTUNE KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13685735
MDR Text Key286732427
Report Number1818910-2022-04165
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295041092
UDI-Public10603295041092
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/07/2022
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
Device Operator Health Professional
Device Model Number1504-00-108
Device Catalogue Number150400108
Device Lot NumberJC1948
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2022
Initial Date FDA Received03/07/2022
Supplement Dates Manufacturer Received03/14/2022
Supplement Dates FDA Received03/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ATTUNE CR FB INSRT SZ 8 8MM.; ATTUNE FB TIB BASE SZ 7 CEM.; ATTUNE MEDIAL DOME PAT 41MM.; ATTUNE MEDIAL DOME PAT 41MM.
Patient Outcome(s) Required Intervention;
Patient Age79 YR
Patient SexMale
Patient Weight91 KG
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