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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

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DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-00-005
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Removal of primary attune due to tibial tray loosening.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.
 
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Brand Name
ATTUNE FB TIB BASE SZ 5 CEM
Type of Device
ATTUNE IMPLANT : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10482024
MDR Text Key205276231
Report Number1818910-2020-19239
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295042396
UDI-Public10603295042396
Combination Product (y/n)N
PMA/PMN Number
K101433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1506-00-005
Device Catalogue Number150600005
Device Lot Number8541369
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/10/2020
Initial Date FDA Received09/02/2020
Supplement Dates Manufacturer Received09/24/2020
Supplement Dates FDA Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE CR FB INSRT SZ 5 6MM; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE CR FB INSRT SZ 5 6MM; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE MEDIAL DOME PAT 35MM
Patient Outcome(s) Required Intervention;
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