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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 151640507
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 09/09/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
The patient was revised due to pain.Doi: (b)(6) 2020 - dor: (b)(6) 2021 (right knee).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: udi (b)(4).
 
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Brand Name
ATTUNE PS FB INSRT SZ 5 7MM
Type of Device
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12531824
MDR Text Key273295063
Report Number1818910-2021-21112
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K111433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number151640507
Was Device Available for Evaluation? No
Date Manufacturer Received10/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DEPUY BONE CEMENT; DEPUY BONE CEMENT; SZ 5/7MM FB PS ATTUNE POLY; DEPUY BONE CEMENT; SZ 5/7MM FB PS ATTUNE POLY
Patient Outcome(s) Required Intervention;
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