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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 S-ROM*SLEEVE PRX ZT HA 20D-LRG HIP FEMORAL STEM/SLEEVE

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DEPUY IRELAND 9616671 S-ROM*SLEEVE PRX ZT HA 20D-LRG HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 550113
Device Problem Loss of Osseointegration (2408)
Patient Problem No Information (3190)
Event Date 02/03/2017
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
Reason for revision: srom femoral prosthesis loosening - sleeve and stem.
 
Manufacturer Narrative
The complaint states second revision right total hip arthroplasty. Primary operation date: unknown. First revision date: (b)(6) 2014 mater hospital sydney. Second revision date: (b)(6) 2017. Reason for revision: srom femoral prosthesis loosening - sleeve and stem. Removal of srom stem, sleeve and ceramic head. Removal of ceramic liner. X-ray photos, explanted implant photos and photos of first revision component implant stickers available. A complaint database search did not identify any anomalies. A review of manufacturing records did not identify any anomalies. 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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Type of DeviceHIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork, muenster
EI
Manufacturer (Section G)
DEPUY IRELAND 9611671
loughbeg, ringaskiddy co.
cork, muenster
EI
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6342281
MDR Text Key67800803
Report Number1818910-2017-12886
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K912713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number550113
Device Lot Number3348045
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/18/2017 Patient Sequence Number: 1
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