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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 46MM OD; HIP FEMORAL HEAD

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JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043 MODULAR CATHCART BALL 46MM OD; HIP FEMORAL HEAD Back to Search Results
Catalog Number 136346000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Fall (1848)
Event Date 03/08/2017
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.(b)(4).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 had a hemi hip replacement for a #nof and since this has fallen and dislocated her hip which required a closed reduction.This patient has again fallen , dislocating their hip joint.The surgeon was unable to reduce the hip joint and the implants were then removed.
 
Manufacturer Narrative
Conclusion and justification status: the complaint states procedure: hemi hip replacement.The patient had a hemi hip replacement for a #nof and since this has fallen and dislocated her hip which required a closed reduction.This patient has again fallen , dislocating their hip joint.The surgeon was unable to reduce the hip joint and the implants were then removed.Specimens were taken to test for infection.The stem was easily removed from the cement mantle after the head and sleeve had been removed.Primary procedure (b)(6) 2017.No other supporting data is available.A complaint database search and review of manufacturing records did not identify any anomalies.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).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)
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 Key6436894
MDR Text Key70967911
Report Number1818910-2017-15423
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 foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 03/08/2017
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 NumberD16031340
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/08/2017
Initial Date FDA Received03/27/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2016
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;
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