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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 20X15X145 42 S-ROM HIP SYSTEM : HIP FEMORAL STEM

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DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 20X15X145 42 S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 900541210
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. 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.
 
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) 2013 via tha. It was confirmed that there was like tumor on the lateral side of femur recently, and although the patient was under observation, the patient had started to complain of pain. Thus, the revision surgery was performed on (b)(6) 2020 by replacing the stem (p/n: unknown), the head (p/n: unknown), the liner (p/n: unknown), the hole eliminator (p/n: unknown). It was judged that it was armd because the stem-neck junction had been discolored to black. The hip joint was filled with pseudotumor and it was scraped as much as possible. The tumor on the lateral side of femur was disappeared by scraping the pseudotumor. There was a possibility of the pseudotumor had been pushed from inside of the joint to the lateral part of the femur. The surgery was completed within a 30 minutes surgical delay. No further information is available.
 
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Brand NameSROM 9/10 20X15X145 42
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 Key9711968
MDR Text Key184613374
Report Number1818910-2020-04904
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K083642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number900541210
Device Lot Number2967454
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
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: 02/14/2020 Patient Sequence Number: 1
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