• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 MODULAR CATHCART BALL 43MM OD HIP FEMORAL HEAD

  • 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
 

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 MODULAR CATHCART BALL 43MM OD HIP FEMORAL HEAD Back to Search Results
Catalog Number 136343000
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 06/27/2017
Event Type  Injury  
Manufacturer Narrative
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, post market surveillance, 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient was revised to address pain.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMODULAR CATHCART BALL 43MM OD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou, jiangsu 21512 -6
CH 21512-6
Manufacturer (Section G)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou, jiangsu 21512 -6
CH 21512-6
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6743479
MDR Text Key104173700
Report Number1818910-2017-21771
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number136343000
Device Lot NumberD14070581
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/26/2017 Patient Sequence Number: 1
-
-