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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL 40MM BCH FEMORAL HEAD; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL 40MM BCH FEMORAL HEAD; HIP COMPONENT Back to Search Results
Model Number 38CH4000
Medical Device Problem Codes Material Disintegration (1177); Naturally Worn (2988)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, 3 years post operatively the patient felt squeaking and limited range of motion.Liner was not in dynasty cup.It was disassembled and they sucked out about 180cc of black oil out of the capsule.Product not revised: cup.
 
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Brand Name
CONSERVE TOTAL 40MM BCH FEMORAL HEAD
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9598038
Report Number3010536692-2020-00054
Device Sequence Number14246756
Product Code LZO
UDI-Device IdentifierM68438CH40001
UDI-PublicM68438CH40001
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K072656
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/05/2020
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 Other
Device Model Number38CH4000
Device Catalogue Number38CH4000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/16/2019
Initial Date Received by Manufacturer 12/16/2019
Supplement Date Received by Manufacturer12/16/2019
Initial Report FDA Received Date01/16/2020
Supplement Report FDA Received Date06/05/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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