Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL INSERT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL INSERT Back to Search Results
Catalog Number UNK ATTUNE KNEE TIBIAL INSERT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Muscular Rigidity (1968)
Event Date 03/31/2021
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
The patient was revised to address stiffness.Doi: unknown, dor: (b)(6) 2021, right knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNK ATTUNE KNEE TIBIAL INSERT
Type of Device
ATTUNE KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11671937
MDR Text Key245598344
Report Number1818910-2021-08016
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/31/2021
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? No
Device Operator Health Professional
Device Catalogue NumberUNK ATTUNE KNEE TIBIAL INSERT
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/31/2021
Initial Date FDA Received04/15/2021
Supplement Dates Manufacturer Received04/21/2021
Supplement Dates FDA Received04/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE FEMORAL COMPONENT SIZE 7; ATTUNE PS INSERT; ATTUNE TIBIA SIZE 7; ATTUNE FEMORAL COMPONENT SIZE 7; ATTUNE PS INSERT; ATTUNE TIBIA SIZE 7
Patient Outcome(s) Required Intervention;
-
-