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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 Fracture (1260); Use of Device Problem (1670); Malposition of Device (2616)
Patient Problems Not Applicable (3189); No Code Available (3191)
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) 2016 via tha. It was reported that it was confirmed the stem (p/n: 900525210) and the sleeve (p/n: 550504) fracture by x-ray when the patient visited to the hospital on (b)(6) 2019, and the patient¿s condition was unwalkable. Thus, the revision surgery was scheduled to be performed in the near future (date of surgery was not fixed yet). Possible cause: the implants in question had been placed in a little bit varus at the primary surgery. No further information is available.
 
Manufacturer Narrative
Product complaint # (b)(4). (b)(4) used to capture the surgical intervention and medical device removal.
 
Event Description
Additional information received confirmed that there was a 30 minute surgical delay.
 
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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 Key9505554
MDR Text Key173980745
Report Number1818910-2019-124447
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number900549210
Device Lot Number8252270
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 Received02/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2016
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: 12/20/2019 Patient Sequence Number: 1
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