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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-00-106
Device Problem Noise, Audible (3273)
Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Initial reporter occupation: lawyer. Investigation summary: the device associated with this report was not received for examination. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The patient underwent a left knee revision due to tibial tray loosening at the cement to implant interface, arthrofibrosis, and decreased range of motion. Depuy cement was used during the primary operation. Ad 18 jun 2021: litigation record received. Litigation record alleges severe and persistent pain, discomfort, instability, popping and clicking of device, difficulty ambulating, loss of mobility, loss of range of motion, mental anguish, loosening and migration of the tibial component. Doi: (b)(6) 2014, dor: (b)(6) 2018, left knee.
 
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Brand NameATTUNE CR FEM LT SZ 6 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 Key12124256
MDR Text Key261255734
Report Number1818910-2021-14399
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295041078
UDI-Public10603295041078
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
Report Date 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1504-00-106
Device Catalogue Number150400106
Device Lot Number7791322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2013
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: 07/06/2021 Patient Sequence Number: 1
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