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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 Pain (1994)
Date of Event 06/09/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was reported that a patient went to the er with right hip pain after she felt a pop.An ortho dislocation reduction procedure was performed under sedation and the patient was discharged with a knee immobilizer.Review of the device history record indicates that the device was manufactured to specification.
 
Event or Problem Description
It was reported that a patient went to the er with right hip pain after she felt a pop.An ortho dislocation reduction procedure was performed under sedation and the patient was discharged with a knee immobilizer.
 
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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
MDR Report Key10215459
Report Number3004153240-2020-00115
Device Sequence Number11613220
Product Code LPH
UDI-Device IdentifierM572HBS0330000011
UDI-Public+M572HBS0330000011
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K192198
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/30/2020
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 06/10/2020
Initial Report FDA Received Date06/30/2020
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 Required Intervention;
Patient Age71 YR
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