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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-105
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Fall (1848); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/26/2019
Event Type  Injury  
Manufacturer Narrative

(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

Patient received a left attune total knee to treat osteoarthritis. The patella was resurfaced and depuy cement x 2 was utilized. There were no indicated intra-operative complications. Patient received a left knee revision to address pain, falls, adhesions, effusion, instability, synovitis, and tibial tray loosening at the cement to implant interface. The surgeon noted minimal bone loss when removing the femoral component. The surgeon also noted some mild compression of the bone in the region of tibial tray loosening with no additional information given. The tibial insert, tibial tray, and femoral component were revised. The patellar component was retained. The patient was revised with competitor products and cement. There were no indicated intra-operative complications. Doi: (b)(6) 2016; dor: (b)(6) 2019; left knee.

 
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Brand NameATTUNE PS FEM LT SZ 5 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 Key11447515
MDR Text Key238910031
Report Number1818910-2021-04779
Device Sequence Number1
Product Code OIY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP830055
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 02/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1504-10-105
Device Catalogue Number150410105
Device LOT Number8427030
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 Received04/12/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/29/2016
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: 03/09/2021 Patient Sequence Number: 1
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