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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FB INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

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DEPUY IRELAND 9616671 ATTUNE CR FB INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 151620608
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/18/2019
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
 
Event Description
After an attune surgery, it was seen that an attune pe inlay with an expiry date nov.2018 was implanted.No surgery delay, no adverse consequences for patient reported.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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.
 
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Brand Name
ATTUNE CR FB INSRT SZ 6 8MM
Type of Device
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key8332262
MDR Text Key135930704
Report Number1818910-2019-84236
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295045793
UDI-Public10603295045793
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 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number151620608
Device Lot Number7816568
Initial Date Manufacturer Received 01/25/2019
Initial Date FDA Received02/12/2019
Supplement Dates Manufacturer Received03/08/2019
Supplement Dates FDA Received03/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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