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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 47MM OD; HIP FEMORAL HEAD

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JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 MODULAR CATHCART BALL 47MM OD; HIP FEMORAL HEAD Back to Search Results
Catalog Number 136347000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Date 03/29/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Patient was revised to address dislocation after a fall.
 
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.
 
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Brand Name
MODULAR CATHCART BALL 47MM OD
Type of Device
HIP 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 Key6507588
MDR Text Key73261819
Report Number1818910-2017-16765
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 distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number136347000
Device Lot NumberD17010865
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/29/2017
Initial Date FDA Received04/20/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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