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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT

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DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-20-605
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994); Synovitis (2094); Discomfort (2330); Joint Laxity (4526)
Event Date 09/09/2019
Event Type  Injury  
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.

 
Event Description

Initial report: patient was revised to address loosening of the tibial component at the cement to implant interface. Depuy cement manufacturer was used. Doi: (b)(6) 2015. Dor: (b)(6) 2019, left knee. Further information provided: in addition to the previously indicated adverse symptoms the patient was experiencing prior to revision, review also determined the following issues: pain, discomfort, instability, synovitis, and adhesions. During the revision on (b)(6) 2019, only the tibial insert, tibial tray, and cement products were revised.

 
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Brand NameATTUNE CR FB INSRT SZ 6 5MM
Type of DeviceATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
JTE RAYNHAM MFG SITE
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581
6107428552
MDR Report Key11359187
MDR Text Key232860463
Report Number1818910-2021-03574
Device Sequence Number1
Product Code OIY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2020
Device MODEL Number1516-20-605
Device Catalogue Number151620605
Device LOT Number623325
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/06/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/22/2021 Patient Sequence Number: 1
Treatment
ATTUNE CR FEM LT SZ 6 NAR CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 38MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
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