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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043 MODULAR CATHCART BALL 44MM OD HIP FEMORAL HEAD

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JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043 MODULAR CATHCART BALL 44MM OD HIP FEMORAL HEAD Back to Search Results
Catalog Number 136344000
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 06/21/2017
Event Type  Injury  
Manufacturer Narrative
No device associated with this report was received for examination. 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
Depuy considers the investigation closed at this time. Should the 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
Update aug 14, 2017: additional information received. The summit basic stem loose. Loosening occurred from bone to implant interface. This complaint was updated on aug 15, 2017.
 
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
The patient was revised to address pain.
 
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Brand NameMODULAR CATHCART BALL 44MM OD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043
no.299 changyang st
suzhou industrial park
suzhou IN 21512 -6
CH 21512-6
Manufacturer (Section G)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043
no.299 changyang st
suzhou industrial park
suzhou IN 21512 -6
CH 21512-6
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6731268
MDR Text Key104048271
Report Number1818910-2017-21449
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,Followup
Report Date 06/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number136344000
Device Lot NumberD16040572
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 Received08/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2016
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: 07/21/2017 Patient Sequence Number: 1
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