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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-124
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/19/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
On (b)(6) 2019, the patient underwent a second left knee revision to address pain. The surgeon noted the removal of scar tissue. The tibial insert, tibial tray, and femoral component were revised. The patellar component was retained. The surgeon noted minimal bone loss with removal of the femoral component. The patient was revised with depuy products. There were no indicated intra-operative complications. Doi: (b)(6) 2018 insert; doi: (b)(6) 2017 femoral, tibial tray; dor: (b)(6) 2019; left knee.
 
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Brand NameATTUNE PS FEM LT SZ 4 NAR CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12290234
MDR Text Key265490814
Report Number1818910-2021-17359
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295041696
UDI-Public10603295041696
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1504-10-124
Device Catalogue Number150410124
Device Lot Number8469273
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2017
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: 08/06/2021 Patient Sequence Number: 1
Treatment
ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 4 10MM; ATTUNE PS FEM LT SZ 4 NAR CEM
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