• 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. 1818910 UNKNOWN 10X75 STEM TRIAL HIP INSTRUMENT/TRIAL

  • 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. 1818910 UNKNOWN 10X75 STEM TRIAL HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number UNK-HIP
Device Problem Connection Problem (2900)
Patient Problem No Information (3190)
Event Date 07/11/2017
Event Type  Injury  
Manufacturer Narrative
The device associated with this report was not returned for evaluation. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will 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.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. Complete product detail has not been received at this time. If further information is received a follow-up medwatch will be filed as appropriate.
 
Event Description
Der states that preparing to implant a stemmed, sleeved mbt revision tray. Used a 10mmx115mm reamer and attempted to place the first conical reamer with the 115x75 stem trial. The proximal end of the stem trial (where the trial locks into the reamer) is so much larger than the reamer it would not allow the physician to fully pass the conical reamer. Forced to use larger reamers in a freehand manner to allow the conical reamers to pass. Added plenty of time and frustration to the case.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN 10X75 STEM TRIAL
Type of DeviceHIP INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6777836
MDR Text Key104175086
Report Number1818910-2017-22423
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK-HIP
Device Lot NumberUNKNOWN
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 Received09/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-