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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 S-ROM HIP SYSTEM : HIP FEMORAL STEM

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DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 14X9X125 30 S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 900526210
Device Problems Fracture; Loss of Osseointegration; Migration
Event Date 09/10/2019
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) 2007 on the patient¿s right hip joint via tha. It was reported that the revision surgery was performed on (b)(6) 2019 by replacing the head (p/n: 1521900579), the liner (p/n: 124148000), the stem (p/n: 900526210) with the sleeve (p/n: 550501) due to looseness, breakage of the stem, thigh pain caused by sinking of the stem. The surgery was completed, and it was unknown whether there was a surgical delay or not. Doctor's view: size mismatch. No further information is available.

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary ==> no device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may 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 NameSROM 9/10 14X9X125 30
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
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key9140338
Report Number1818910-2019-107007
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number900526210
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 Received11/28/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/01/2019 Patient Sequence Number: 1
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