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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

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DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-00-007
Device Problems Loss of or Failure to Bond (1068); Migration (4003)
Patient Problems Pain (1994); Synovitis (2094); Not Applicable (3189); No Code Available (3191)
Event Date 04/19/2017
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Reviewed medical records received on 11 may 2018.Left knee revised to address pain, instability, medial tibial collapse, and aseptic loosening of the tibia base plate at the cement to implant interface.Revising surgeon identified a very villous synovitis, consistent with implant loosening.He indicated femur and patella components were well-fixed, but the tibia base plate was loose at the cement to implant interface.Tibia cement mantle was not loose with respect to tibia bone.Femur, tibia, and insert were revised; patella tracked well, with no baja, so it was retained.Doi: (b)(6) 2014; dor: (b)(6) 2017; (left knee).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: b1 and h6 (patient and device codes).H6 patient code: no code available (3191) used to capture the surgical intervention and joint instability.
 
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Brand Name
ATTUNE FB TIB BASE SZ 7 CEM
Type of Device
ATTUNE IMPLANT : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key7578581
MDR Text Key110381282
Report Number1818910-2018-61598
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295042419
UDI-Public10603295042419
Combination Product (y/n)N
PMA/PMN Number
K101433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Model Number1506-00-007
Device Catalogue Number150600007
Device Lot Number3509553
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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