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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Pneumonia (2011); Heart Failure (2206); Joint Dislocation (2374); No Code Available (3191)
Event Date 05/21/2015
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. (b)(4).
 
Event Description
The literature article entitled, "total hip arthroplasty using non-modular cementless long-stem distal fixation for salvage of failed internal fixation of intertrochanteric fracture" written by xiaojun shi, md, zongke zhou, md, phd, jing yang, md, bin shen, md, pengde kang, md, phd, and fuxing pei, md on 21 may 2015 was reviewed for mdr reportability. The article reports on "all the patients had femoral reconstruction using a non-modular solution stem" (depuy). The mean follow up after salvage tha was 47. 5 months and 3 of 31 patients died of unrelated diseases with the implant intact. Functional outcomes include: residual trochanteric low grade pain with no compromise of activities (6); limb-length discrepancy with a mean value of 7 mm - range of 5-15 mm (12); positive trendelenburg (denoting hip abductor weakness) in all patients but progressively diminished until all became negative. Complications: intraoperative nondisplaced femoral fracture treated with cerclage wire (2); dislocations within 2 weeks of initial implant successfully treated with closed reduction and bracing (2); delirium (1); pneumonia (1); and congestive heart failure (1). The article states, "there were no cases of nerve palsy or perioperative deaths. " no further information provided on identity of other components besides the stem. No further information provided of further interventions for the complications. Impacted product: depuy solution stem.
 
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 NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 46581-0988
6107428552
MDR Report Key9154300
MDR Text Key167779755
Report Number1818910-2019-107386
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received12/03/2019
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

Patient Treatment Data
Date Received: 10/03/2019 Patient Sequence Number: 1
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