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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. CONFORMIS HIP SYSTEM; HIP REPLACEMENT SYSTEM
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CONFORMIS, INC. CONFORMIS HIP SYSTEM; HIP REPLACEMENT SYSTEM Back to Search Results
Catalog Number HCC-032-0000
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was planned to a 54 cup and 36 head (group d liner).However, a group e liner was in box 1.The case was completed successfully with a correct liner from box 2.Review of the device history record indicates that the device was manufactured to specification.
 
Event or Problem Description
It was reported that the patient was planned to a 54 cup and 36 head (group d liner).However, a group e liner was in box 1.The case was completed successfully with a correct liner from box 2.
 
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Brand Name
CONFORMIS HIP SYSTEM
Common Device Name
HIP REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
MDR Report Key8211994
Report Number3004153240-2019-00004
Device Sequence Number11423113
Product Code LPH
UDI-Device IdentifierM572HCC0320000011
UDI-Public+M572HCC0320000011
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K162719
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/26/2018
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 Catalogue NumberHCC-032-0000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/04/2018
Initial Report FDA Received Date01/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age69 YR
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