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. DEPUY PINNACLE SECTOR SHELL; PROSTHESIS, HIP
  • 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. DEPUY PINNACLE SECTOR SHELL; PROSTHESIS, HIP Back to Search Results
Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem Pain (1994)
Event Date 03/30/2017
Event Type  Injury  
Event Description
I had a hip replacement on (b)(6) 2015 using a depuy pinnacle sector acetabular shell and a depuy summit ha ingrown stem.I had no problem until (b)(6) 2017 when i had noise and pain in my left hip.I saw the dr and found that i needed to have a revision which was done on (b)(6) 2017 due to the plastic component failing the polyethylene liner had dissociated with result in the ceramic femoral head articulating on the pinnacle shell.There was a large amount of titanium painting on the femoral head from coming into contact with the acetabular shell, the dr who did the revision stated he had never seen a prosthesis fail like this and he does revisions.This prosthesis only lasted 21 months and should have lasted longer.The prosthesis was sent to depuy that day as the rep was at the hospital.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEPUY PINNACLE SECTOR SHELL
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
MDR Report Key7472331
MDR Text Key107020823
Report NumberMW5076860
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/02/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/27/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age64 YR
Patient Weight93
-
-