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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J & J MEDICAL (SUZHOU) LTD. - REG. # 3006356043 MODULAR CATHCART BALL 46MM OD; HIP FEMORAL HEAD

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J & J MEDICAL (SUZHOU) LTD. - REG. # 3006356043 MODULAR CATHCART BALL 46MM OD; HIP FEMORAL HEAD Back to Search Results
Catalog Number 136346000
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 01/27/2017
Event Type  Injury  
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event Description
Patient was revised to address an infection.
 
Manufacturer Narrative
Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.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 46MM OD
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
J & J MEDICAL (SUZHOU) LTD. - REG. # 3006356043
no.299 changyang st
suzhou industrial park
suzhou 21512 -6
CH  21512-6
Manufacturer (Section G)
J & J MEDICAL (SUZHOU) LTD. - REG. # 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 Key6298151
MDR Text Key66429697
Report Number1818910-2017-11814
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 01/27/2017
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 Number136346000
Device Lot NumberD16010291
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2017
Initial Date FDA Received02/02/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2016
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 Age87 YR
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