• 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 SELF CENT HIP 42X28 RUST HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

  • 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 SELF CENT HIP 42X28 RUST HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Catalog Number 103542000
Device Problem Fitting Problem (2183)
Patient Problem Not Applicable (3189)
Event Date 11/23/2018
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 patient had a femoral neck fracture and needed a hemi arthroplasty to repair. After successfully trailing components and then inserting the real femoral stem, a 42mm bipolar head and 28mm +5 metal head were opened for implantation. After carefully removing the plastic portion from the 42mm shell, the 28 mm metal head was inserted into the plastic, but did not spin freely but only under significant force.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSELF CENT HIP 42X28 RUST
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6103142063
MDR Report Key8178859
MDR Text Key130821986
Report Number1818910-2018-78646
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number103542000
Device Lot NumberH56827
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

-
-