• 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 MBT REV PRIMARY CONICAL REAMER; KNEE INSTRUMENT : REAMERS

  • 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 MBT REV PRIMARY CONICAL REAMER; KNEE INSTRUMENT : REAMERS Back to Search Results
Catalog Number 217863199
Device Problem Naturally Worn (2988)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination and functional testing of the returned device confirmed the reported event.Depuy 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.
 
Event Description
It was reported that the reamer and the reamer adapter connections are worn and need to be replaced.No surgical delay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MBT REV PRIMARY CONICAL REAMER
Type of Device
KNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6107428552
MDR Report Key8200306
MDR Text Key131535397
Report Number1818910-2018-79252
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295096535
UDI-Public10603295096535
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/30/2018
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
Device Operator Health Professional
Device Catalogue Number217863199
Device Lot NumberPG0608
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2018
Initial Date FDA Received12/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2008
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-