• 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 UNKNOWN HIP FEMORAL HEAD

  • 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 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
Event Date 08/18/2020
Event Type  Injury  
Manufacturer Narrative
(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
A patient presented with a build up of inflammatory tissue around their previous total hip replacement.The surgeon was concerned it may be tumor and/or infection.The patient had a previous metal on metal hip using summit/pinnacle from the early 2000s and was revised to a poly liner with a ceramic biolox delta ts femoral head in 2019.In this surgery, the surgeon removed all of the "inflammatory tissue" and revised the femoral head to a longer head (36mm+12).No information regarding product numbers and/or lot numbers was provided and the hospital is not providing that information at this time.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN HIP FEMORAL HEAD
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10502184
MDR Text Key205943192
Report Number1818910-2020-19511
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Date Manufacturer Received09/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-