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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 Problems Use of Device Problem (1670); Loss of Osseointegration (2408); Malposition of Device (2616)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 10/19/2019
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. (b)(4).

 
Event Description

The literature article entitled, "the effect of size for a hydroxyapatite-coated cementless implant on component revision in total hip arthroplasty: an analysis of 41,265 stems" written by wayne t. Hoskins, phd, roger j. Bingham, fracs, michelle lorimer, and richard n. De steiger, phd, fracs (orth) published by the journal of arthroplasty accepted by publisher 30 october 2019 was reviewed. The article's purpose was to investigate whether there was a difference in revision rate for smaller stems with focus on depuy corail stems. Data was compiled from 41,265 primary thas from the australian orthopaedic association national joint replacement registry. The article notes that the smaller corail stems have 4 times the rate of revision compared with the larger femoral sizes. It is assumed that the corail stems were utilized with depuy femoral heads, cups and liners. Depuy products identified: corail stem. Adverse events: revisions for loosening, dislocation, infection, femur fracture and malposition. No further information provided regarding reasons for revision.

 
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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
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9636094
MDR Text Key188195542
Report Number1818910-2020-03137
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received02/18/2020
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: 01/28/2020 Patient Sequence Number: 1
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