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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 HAA-050-D001
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was discovered that the iview for the 32xl femoral head where the leg length and femoral offsets were miscalculated.The case was completed successfully.Review of the device history record confirmed the miscalculation.It is unlikely that this adverse event, will be noticed by the patient.
 
Event or Problem Description
It was discovered that the iview for the 32xl femoral head where the leg length and femoral offsets were miscalculated.The case was completed successfully.
 
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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 Key8085807
Report Number3004153240-2018-00259
Device Sequence Number11114296
Product Code LPH
UDI-Device IdentifierM572HAA050D001011
UDI-Public+M572HAA050D001011
Combination Product (Y/N)N
Initial Reporter StateMA
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 company representative
Initial Reporter Occupation Administrator/Supervisor
Remedial Action Notification
Type of Report Initial
Report Date (Section B) 11/19/2018
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 Expiration Date09/30/2019
Device Catalogue NumberHAA-050-D001
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/22/2018
Initial Report FDA Received Date11/19/2018
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 Congenital Anomaly;
Patient Age66 YR
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