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 PFCSIG INS TRL CURVD 15MMSZ2.5; 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 PFCSIG INS TRL CURVD 15MMSZ2.5; KNEE INSTRUMENT : TIBIAL TRIALS Back to Search Results
Catalog Number 961343
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/07/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Trials are worn and chipped through multiple use, hospital are not prepared to re sterilise.
 
Additional Manufacturer Narrative
Product complaint # : (b)(4).The reported event has been evaluated and will be monitored.Depuy synthes considers the investigation closed at this time.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PFCSIG INS TRL CURVD 15MMSZ2.5
Common Device Name
KNEE INSTRUMENT : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8117187
Report Number1818910-2018-76683
Device Sequence Number295691
Product Code LXH
UDI-Device Identifier10603295237167
UDI-Public10603295237167
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/07/2018
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 Number961343
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/07/2018
Supplement Date Received by Manufacturer12/14/2018
Initial Report FDA Received Date11/29/2018
Supplement Report FDA Received Date01/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-