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: HOWMEDICA/OSTEONIC FEMORAL HEAD LOW FRICTION ION TREATMENT; FEMORAL HEAD V-40
  • 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
 

HOWMEDICA/OSTEONIC FEMORAL HEAD LOW FRICTION ION TREATMENT; FEMORAL HEAD V-40 Back to Search Results
Model Number 6260-9-236
Device Problems Crack (1135); Material Erosion (1214); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Date 04/26/2013
Event Type  Injury  
Event Description
On (b)(6) 2013, i had a failure of a total hip replacement.During the hip-revision operation it was found that the trunnion of the stem was whittled down to a sharp point.Rather than being a 10 - 12 summer stem, it had become approximately 4mm.It had eroded down the anterior corner of the acetabular component by the locking mechanism, and had removed the containment bar that holds the ring lock portion of the cup.As a consequence the liner was loose.The head was located in the ball and the trunnion up high.Failed parts: stem how/ost (b)(4) accolade tmzf plus hip stem#3 head.How/ost (b)(4) femoral head low friction ion treatment shell: zimmer (b)(4) trilogy acetabular shell with cluster holes porous 52mm od liner: zimmer (b)(4) trilogy acetabular system liner standard.On (b)(6) 2013 preoperative x-ray report "it appears that the femoral component of the left hip arthroplasty may be dislocated outside of the acetabular component.The prosthetic neck is also angulated.A lucent line is visible in the proximal femur on one view only.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FEMORAL HEAD LOW FRICTION ION TREATMENT
Type of Device
FEMORAL HEAD V-40
Manufacturer (Section D)
HOWMEDICA/OSTEONIC
MDR Report Key3870213
MDR Text Key4566504
Report NumberMW5036540
Device Sequence Number2
Product Code KXA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/05/2014
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received06/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6260-9-236
Device Catalogue Number6260-9-236
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age65 YR
Patient Weight86
-
-