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 ENDURON NEUT 62 OR 74ODX28ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
  • 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 ENDURON NEUT 62 OR 74ODX28ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 124122025
Device Problem Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Date 01/14/2021
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
It was reported that poly wear and metal wear was the reason for revision.Original implant date unknown.Doi: unknown, dor: (b)(6) 2021, left hip.
 
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 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 device history record (mre) review, was not possible because the required lot code was not provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDURON NEUT 62 OR 74ODX28ID
Type of Device
DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11238237
MDR Text Key228964076
Report Number1818910-2021-01919
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
K944538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number124122025
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARTICULEZE M 28MM 1.5; DURALOC SECTOR SERIES 62OD; ENDURON NEUT 62 OR 74ODX28ID; ARTICULEZE M 28MM 1.5; DURALOC SECTOR SERIES 62OD; ENDURON NEUT 62 OR 74ODX28ID
Patient Outcome(s) Required Intervention;
-
-