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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THEKEN COMPANIES INSITU HIP SYSTEM; TOTAL HIP REPLACEMENT SYSTEM
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THEKEN COMPANIES INSITU HIP SYSTEM; TOTAL HIP REPLACEMENT SYSTEM Back to Search Results
Model Number 10-11-0007
Health Effect - Clinical Codes Bone Fracture(s) (1870); No Code Available (3191)
Date of Event 05/15/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Upon investigation of the complaint, it was determined that there is no indication of a malfunction of the implants and a reason for the bone fracture was not determined.Revision surgery was performed on (b)(6) 2017.No further incidents with the patient have been reported.
 
Event or Problem Description
Patient was x-rayed at 4 weeks post op.Fracture was identified just distal of femoral stem.Revision surgery was performed on (b)(6) 2017 with longer stem and cable plate.
 
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Brand Name
INSITU HIP SYSTEM
Common Device Name
TOTAL HIP REPLACEMENT SYSTEM
Manufacturer (Section D)
THEKEN COMPANIES
1800 triplett blvd
akron OH 44306
MDR Report Key7042062
Report Number3002498892-2017-00001
Device Sequence Number977426
Product Code LZO
UDI-Device Identifier00816127022142
UDI-Public00816127022142
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date10/01/2018
Device Model Number10-11-0007
Device Catalogue Number10-11-0007
Device Lot NumberPC021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/15/2017
Initial Report FDA Received Date11/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
Patient Age80 YR
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