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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 Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
Patient Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)
Event Date 07/04/2011
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

"literature article entitled, ¿femoral revision surgery with impaction bone grafting¿ by b. L. E. F. Ten have, et al, published by the journal of bone and joint surgery (2012), vol. 94-b, no. 5, pp. 615-618, was reviewed. The purpose of this prospective study was to evaluate the long-term clinical and radiological outcomes of revision of the femoral component of a total hip replacement using impaction bone grafting in 29 patients between september 1992 and september 1995. The article studies the outcomes of a competitor stem and head implanted during revision surgery. This complaint will capture the depuy components that were explanted during the revision surgery. Revised depuy products: 10 charnley stems and 3 minneapolis stems. The stems were paired with depuy femoral heads. Reasons for revision: aseptic loosening, pain, and periprosthetic fracture. The authors do not identify the reasons for revision by device manufacturer. The actual number of depuy stems associated with the following reasons for revision are unknown. There were no reported product problems with the femoral heads. Captured in this complaint: 13 stems: implant loosening of an unknown interface; fracture, pain, surgical intervention, medical device removal. 13 femoral heads: no reported product problem; pain, surgical intervention, and medical device removal. ".

 
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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
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key9601441
MDR Text Key188186266
Report Number1818910-2020-02095
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeNL
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 01/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2020
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 Received01/29/2020
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: 01/17/2020 Patient Sequence Number: 1
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