• 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 STEM

  • 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 STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)
Patient Problems Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)
Event Date 04/11/2014
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. (b)(4).
 
Event Description
"the literature article entitled, "revision of ceramic head fracture after third generation ceramic-on-ceramic total hip arthroplasty" written by kyung-hoi koo, md, yong-chan ha, md, shin-yoon kim, md, kang-sup yoon, md, byung-woo min, md, and sang-rim kim, md published by the journal of arthroplasty 29 (2014) 214-218 was reviewed. The article's purpose: "we followed patients who underwent revision total hip arthroplasty specifically to treat a ceramic head fracture after third generation ceramic-on-ceramic tha. We evaluated the results, identified complications and suggest a potential guideline of the revision for contemporary ceramic head fractures. " the article captures 24 patients in a table on page 215 but only 4 have depuy products and have been captured individually in linked complaints. " this complaint captures patient #12 (b)(6) year old male with corail stem and unspecified acetabular component (assumed to be depuy) and received revision 23 months due to fracture of ceramic head with retained stem to a mop bearing change. He then experienced persistent thigh pain and 25 months after the index revision he was diagnosed with stem loosening (his radiographic image showed subsidence of 3 mm) and was revised to a longer stem, a ceramic head and poly liner. There is no indication that the migration was progressive and the diagnosis was stem loosening for revision reason.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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 NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9282857
MDR Text Key184851664
Report Number1818910-2019-110986
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received01/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/05/2019 Patient Sequence Number: 1
-
-