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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL HIP G2; HIP REPLACEMENT SYSTEM
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CONFORMIS, INC. ITOTAL HIP G2; HIP REPLACEMENT SYSTEM Back to Search Results
Model Number HBS033000001
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was reported that the surgeon went to utilize the patient-specific stem and said it was too short.The surgeon used a stem from a different company to complete the surgery.Review of the device history record indicates that the device was manufactured to specification.
 
Event or Problem Description
It was reported that the surgeon went to utilize the patient-specific stem and said it was too short.The surgeon used a stem from a different company to complete the surgery.
 
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Brand Name
ITOTAL HIP G2
Common Device Name
HIP REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
MDR Report Key11566261
Report Number3004153240-2021-00034
Device Sequence Number17195098
Product Code LPH
UDI-Device IdentifierM572HBS0330000011
UDI-Public+M572HBS0330000011
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K192198
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberHBS033000001
Device Catalogue NumberHBS-033-0000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/01/2021
Initial Report FDA Received Date03/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age68 YR
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