• 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 43X28 GRY 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 43X28 GRY HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-43-000
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
Event Type  malfunction  
Event Description
It was reported that the dr. Inserted the head in the polyethylene, introduction into the metal dome, a maneuver that is difficult unlike other times. There remains a slight step of the polyethylene compared to the metal rhyme. The head instead continues to rotate correctly. Use of another system.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSELF CENT HIP 43X28 GRY
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13599876
MDR Text Key286775179
Report Number1818910-2022-03575
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K812672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1035-43-000
Device Catalogue Number103543000
Device Lot NumberJN0168
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2022 Patient Sequence Number: 1
Treatment
UNKNOWN HIP FEMORAL HEAD
-
-