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 US UNK HIP BONE SCREW
  • 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 UNK HIP BONE SCREW Back to Search Results
Catalog Number UNK HIP BONE SCREW
Device Problem Difficult to Advance (2920)
Patient Problems Foreign Body Reaction (1868); No Code Available (3191)
Event Date 09/23/2020
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
It was reported that the liner was either never full engaged with cup or became disassociated from cup.The ceramic femoral head then became in contact with the inner diameter of the acetabular shell.With the ceramic head articulating with the inner diameter of the shell, the shell became compromised causing metallosis and the ceramic head eventually wearing/cutting through the acetabular shell.It is not certain that the liner became disassociated or was improperly placed as there was an unseated screw that was removed.Also, the liner was severely compromised.Doi: (b)(6) 2017.Dor: (b)(6) 2020.Affected side: unknown.
 
Manufacturer Narrative
Product complaint # (b)(4).No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.H10 additional narrative: added: h6 (patient) no code available (3191) is used to capture insufficient information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNK HIP BONE SCREW
Type of Device
BONE SCREW
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10653525
MDR Text Key210574995
Report Number1818910-2020-21835
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP BONE SCREW
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received10/08/2020
Supplement Dates Manufacturer Received11/10/2020
Supplement Dates FDA Received11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALTRX NEUT 36IDX56OD.; DELTA CER HEAD 12/14 36MM +8.5.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN SECTOR W/GRIPTION 56MM.; ALTRX NEUT 36IDX56OD.; DELTA CER HEAD 12/14 36MM +8.5.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN SECTOR W/GRIPTION 56MM.
Patient Outcome(s) Required Intervention;
Patient Age46 YR
-
-