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 PFCSIGM INS TRL STABL12.5MMSZ4; KNEE INSTRUMENT : TIBIAL TRIALS
  • 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 PFCSIGM INS TRL STABL12.5MMSZ4; KNEE INSTRUMENT : TIBIAL TRIALS Back to Search Results
Catalog Number 961452
Medical Device Problem Code Crack (1135)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).Investigation summary : examination of the returned device revealed the rim has broken.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.
 
Event or Problem Description
It was reported that the 4x12.5mm curved insert trial broke around the rim.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PFCSIGM INS TRL STABL12.5MMSZ4
Common Device Name
KNEE INSTRUMENT : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8125266
Report Number1818910-2018-76960
Device Sequence Number1693592
Product Code LXH
UDI-Device Identifier10603295238690
UDI-Public10603295238690
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number961452
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/29/2018
Initial Report FDA Received Date12/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-