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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 14X9X125 30+4 S-ROM HIP SYSTEM : HIP FEMORAL STEM

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DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 14X9X125 30+4 S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 900549210
Device Problems Difficult to Insert (1316); Use of Device Problem (1670); Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 02/07/2020
Event Type  Injury  
Manufacturer Narrative

(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 primary surgery was performed on (b)(6) 2020. It was reported that the revision surgery was performed on (b)(6) 2020 by replacing unknown implant(s) (p/n: unknown) due to dislocation. The surgery was completed, and it was unknown whether there was a surgical delay or not. No further information is available.

 
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Brand NameSROM 9/10 14X9X125 30+4
Type of DeviceS-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9757433
MDR Text Key181329901
Report Number1818910-2020-06066
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 02/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number900549210
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/02/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/26/2020 Patient Sequence Number: 1
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