• 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 ATTUNE RP PS ARTIC SURF SZ6; ATTUNE INSTRUMENTS : TIBIAL TRIALS

  • 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 ATTUNE RP PS ARTIC SURF SZ6; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Model Number 2545-00-546
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  malfunction  
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
Nurse reported a loose duraloc cup impactor which requires replacement (normal wear and tear).In addition, she reported an attune trial liner which lost its balseal and which also requires replacement.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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: the product investigation, found no evidence suspecting an error in the manufacturing or material, that would be a contributing factor in the reported allegation(s), where the product and lot code was provided.A manufacturing records evaluation (mre) was not performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTUNE RP PS ARTIC SURF SZ6
Type of Device
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11516462
MDR Text Key240662214
Report Number1818910-2021-05429
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295132868
UDI-Public10603295132868
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/11/2021
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 Model Number2545-00-546
Device Catalogue Number254500546
Device Lot NumberMVMFVK590
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/11/2021
Initial Date FDA Received03/18/2021
Supplement Dates Manufacturer Received06/04/2021
Supplement Dates FDA Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-