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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 45MM OD; HIP FEMORAL HEAD

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JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 MODULAR CATHCART BALL 45MM OD; HIP FEMORAL HEAD Back to Search Results
Catalog Number 136345000
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 08/18/2017
Event Type  Injury  
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 painful hemi hip.Converted to total hip.
 
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 45MM OD
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou 21512 -6
CH  21512-6
Manufacturer (Section G)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou 21512 -6
CH   21512-6
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6941760
MDR Text Key89135495
Report Number1818910-2017-26370
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032779
UDI-Public10603295032779
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 Health Professional
Type of Report Initial,Followup
Report Date 08/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number136345000
Device Lot NumberD16062163
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2016
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;
Patient Age78 YR
Patient Weight75
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