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 ORTHOPAEDICS INC US ARTICUL TR BALL GRVD 36 +12; HIP INSTRUMENTS : FEMORAL 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 ORTHOPAEDICS INC US ARTICUL TR BALL GRVD 36 +12; HIP INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Model Number 2531-54-000
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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
It was reported that the 32mm and 36mm artic/eze trial heads were worn.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.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).A manufacturing records evaluation (mre) was not performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARTICUL TR BALL GRVD 36 +12
Type of Device
HIP INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12057733
MDR Text Key258173881
Report Number1818910-2021-13476
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295129219
UDI-Public10603295129219
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 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2531-54-000
Device Catalogue Number253154000
Was Device Available for Evaluation? No
Date Manufacturer Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-