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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ACTIS COLLARED HIGH SIZE 7; HIP FEMORAL STEM/SLEEVE

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DEPUY ORTHOPAEDICS, INC. ACTIS COLLARED HIGH SIZE 7; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 101012070
Device Problem Microbial Contamination of Device (2303)
Patient Problems Cardiac Arrest (1762); Unspecified Infection (1930)
Event Date 03/15/2017
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
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
**update received 3/28/17.Clinical report was received stating that patient was revised to address a periprosthetic joint infection.**update received 3/29/17.Clinical report was received stating that the patient suffered from a cardiac arrest resulting in death, relating to the procedure.
 
Manufacturer Narrative
No device associated with this report was received for examination.Depuy considers the investigation closed at this time.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
ACTIS COLLARED HIGH SIZE 7
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6421742
MDR Text Key70485433
Report Number1818910-2017-15057
Device Sequence Number1
Product Code KWL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160907
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,Followup
Report Date 03/15/2017
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 Number101012070
Device Lot NumberH32454
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2017
Initial Date FDA Received03/21/2017
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received04/05/2017
04/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2017
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;
Patient Age63 YR
Patient Weight126
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