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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 8 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 8 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-208
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Event Date 02/25/2021
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
Patient received a right revision of an unknown unicompartmental knee to treat aseptic loosening. A primary attune knee was implanted. The patella was resurfaced and depuy cement x 2 was utilized. The procedure was completed without complications. Patient¿s right knee was revised to treat pain, instability, loss of function, and swelling secondary to suspected tibial tray loosening. Upon entering the joint, a large effusion was evacuated. The surgeon identified and excised extensive periarticular hypertrophic synovitis consistent with polyethylene wear. Upon inspection, the surgeon identified wear and a cold-flow deformation on the insert, with notable backside wear. The tibial tray was loosened and debonded at the cement to implant interface and revised. The surgeon notes the tibial tray had moved into varus due to an osteolytic lesion along the medial tibial plateau that the surgeon attributed to the poly debris generated by the wear from the insert. The femoral component was well fixed but revised to accommodate the revision knee devices. The patella was well-fixed with no signs of wear and retained. The patient was revised with an unknown revision knee system. The procedure was completed without complications. Doi: (b)(6) 2016. Dor: (b)(6) 2021. Right knee.
 
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Brand NameATTUNE PS FEM RT SZ 8 CEM
Type of DeviceATTUNE IMPLANT : 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 Key12370817
MDR Text Key268249267
Report Number1818910-2021-18738
Device Sequence Number1
Product Code OIY
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 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1504-10-208
Device Catalogue Number150410208
Device Lot Number702854
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 Received09/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2015
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: 08/26/2021 Patient Sequence Number: 1
Treatment
ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ8 5MM; ATTUNE RP TIB BASE SZ 8 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
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