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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL HIP G1; HIP REPLACEMENT SYSTEM
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CONFORMIS, INC. ITOTAL HIP G1; HIP REPLACEMENT SYSTEM Back to Search Results
Model Number HCC032000001
Health Effect - Clinical Code No Code Available (3191)
Date of Event 04/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the patient had a post-operative hip dislocation.Revision surgery occurred and the surgeon revised the patient to an off-the-shelf cup and liner.Review of the device history record indicates that the device was manufactured to specification.
 
Event or Problem Description
It was reported that the patient had a post-operative hip dislocation.Revision surgery occurred and the surgeon revised the patient to an off-the-shelf cup and liner.
 
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Brand Name
ITOTAL HIP G1
Common Device Name
HIP REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica, ma
MDR Report Key10022286
Report Number3004153240-2020-00091
Device Sequence Number14131969
Product Code JWH
UDI-Device IdentifierM572HCC0320000011
UDI-Public+M572HCC0320000011
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K162719
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/04/2020
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 Model NumberHCC032000001
Device Catalogue NumberHCC-032-0000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/07/2020
Initial Report FDA Received Date05/04/2020
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 Age62 YR
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