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 EMPHASYS; Hip Implant : Acetabular Liner
  • 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 EMPHASYS; Hip Implant : Acetabular Liner Back to Search Results
Catalog Number 472252040
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/17/2026
Type of Reportable Event Serious Injury
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EMPHASYS
Common Device Name
Hip Implant : Acetabular Liner
Manufacturer (Section D)
DePuy Orthopaedics Inc US
700 orthopaedic drive
warsaw IN 46581 -098
Manufacturer (Section G)
JTE Warsaw Mfg Site
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
elba bello
700 orthpaedic dr.
warsaw, IN 46581
+1(908)386-3534
MDR Report Key50722622
Report Number1818910-2026-15547
Device Sequence Number8862457
Product Code LPH
UDI-Device Identifier10603295501381
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K231873
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2026
Device Explanted Year2026
Reporter Type Manufacturer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Physician
Type of Report Initial
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
Operator of Device Health Professional
Device Catalogue Number472252040
Device Lot Number4885163
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Received by Manufacturer 08/18/2026
Initial Report FDA Received Date09/10/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured08/11/2025
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age57 YR
Patient SexFemale
-
-