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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TECRES S.P.A. EXACTECH; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER
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TECRES S.P.A. EXACTECH; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER Back to Search Results
Lot Number AA9746035
Device Problem Fracture (1260)
Patient Problem Unspecified Infection (1930)
Event Date 08/30/2019
Event Type  Injury  
Event Description
Patient underwent revision of right total hip replacement with mobile bearing acetabular component, open reduction internal fixation of periprosthetic femur fracture; removal of antibiotic spacer debridement of right hip joint and femur; application of negative pressure wound dressing due to recurrent periprosthetic fracture right femur involving antibiotic spacer.The spacer has been in place approximately for 4 months treating a candida lusitaniae and enterobacter infection of a right total hip replacement the spacer was impregnated with voriconazole and amphotericin and anti-bacterial antibiotics as well.Patient also underwent 2 per-operative aspirations approximately a month apart, both of which have been proven negative for infection of bacteria and negative for further infection with candida.
 
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Brand Name
EXACTECH
Type of Device
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER
Manufacturer (Section D)
TECRES S.P.A.
7 trail house court
rockville MD 20850
MDR Report Key10419572
MDR Text Key203314958
Report Number10419572
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/11/2020,08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot NumberAA9746035
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2020
Device Age4 MO
Event Location Other
Date Report to Manufacturer08/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age22265 DA
Patient Weight97
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