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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-107
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Pain (1994)
Event Date 02/25/2019
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
The patient underwent a left total knee arthroplasty without complications on (b)(6) 2015 utilizing attune implants with competitor cement.On (b)(6) 2019, the patient was revised to a competitor system for pain.Intraoperatively, the femoral component was noted to be partially loose at an unknown interface.The surgeon reports he is considering this is loose secondary to ease of removal.While he states that most of the cement was noted to be located on the bone, he does not confirm a specific loosening interface.Doi: (b)(6) 2015.Dor: (b)(6) 2019; (left).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE PS FEM LT SZ 7 CEM
Type of Device
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11590357
MDR Text Key242989612
Report Number1818910-2021-06486
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295041641
UDI-Public10603295041641
Combination Product (y/n)N
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1504-10-107
Device Catalogue Number150410107
Device Lot Number7965802
Was Device Available for Evaluation? No
Date Manufacturer Received05/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 7 5MM; ATTUNE PS FEM LT SZ 7 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 7 5MM; ATTUNE PS FEM LT SZ 7 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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