• 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 MTO PINN CUP IMPACT 18IN ASSY HIP INSTRUMENTS : IMPACTION INSTRUMENTS

  • 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 MTO PINN CUP IMPACT 18IN ASSY HIP INSTRUMENTS : IMPACTION INSTRUMENTS Back to Search Results
Model Number 2999-58-770
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problem Not Applicable (3189)
Event Date 11/11/2019
Event Type  malfunction  
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 Description
It was reported that they attempted to insert gription seater 54 mm shell with mto pinnacle long impactor. After impaction, surgeon was unable to unscrew impactor from cup. Cup had to be removed. Alternative impactor and implant had to be used since parts in even cannot be separated. Ten minutes surgical delay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMTO PINN CUP IMPACT 18IN ASSY
Type of DeviceHIP INSTRUMENTS : IMPACTION INSTRUMENTS
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 46581-0988
6107428552
MDR Report Key9416212
MDR Text Key184248131
Report Number1818910-2019-120675
Device Sequence Number1
Product Code KWA
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2999-58-770
Device Catalogue Number299958770
Device Lot NumberGM4771001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-