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 10D 54OD X 32ID; 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 10D 54OD X 32ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 124254025
Device Problem Naturally Worn (2988)
Patient Problems Edema (1820); Inflammation (1932); No Code Available (3191)
Event Date 04/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.
 
Event Description
Surgeon reported a revision of a duraloc inlay.Doi: unknown, dor: (b)(6) 2019.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative: added: d11.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. .
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDURON 10D 54OD X 32ID
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 Key9557383
MDR Text Key182937746
Report Number1818910-2020-00745
Device Sequence Number1
Product Code HRY
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,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number124254025
Device Lot Number1894919
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Date Manufacturer Received02/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APEX HOLE ELIM POSITIVE STOP.; DURALOC 100 SERIES 54MM OD.; FUTUREHIP HA STEM SZ 7.; HIP BALL BIOLOX 32 +9 12/14.; HIP BALL BIOLOX 32 +9 12/14.; PLA CENTRALISER 14MM.; UNKNOWN HIP FEMORAL HEAD.; UNKNOWN HIP IMPLANT - LOCKING RING.
Patient Outcome(s) Required Intervention;
-
-