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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 SROM 9/10 14X9X125 36 S-ROM HIP SYSTEM : HIP FEMORAL STEM

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DEPUY INTERNATIONAL LTD. 8010379 SROM 9/10 14X9X125 36 S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 900527210
Device Problem Corroded (1131)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Report of taper corrosion.
 
Manufacturer Narrative
Investigation summary 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, a follow-up medwatch will be filed as appropriate.  .
 
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Brand NameSROM 9/10 14X9X125 36
Type of DeviceS-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7910119
MDR Text Key122009962
Report Number1818910-2018-70543
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number900527210
Device Lot Number2828080
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 Received10/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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