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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CERAMIC FEMORAL HEAD; HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CERAMIC FEMORAL HEAD; HIP COMPONENT Back to Search Results
Model Number 26000013
Device Problem Unsealed Device Packaging (1444)
Patient Problem Insufficient Information (4580)
Event Date 12/30/2022
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly, the inner sterile packaging separated during opening of the outer package.In the process we were not sure if the implanted had been contaminated during opening error on the side of caution open a second same thing but we were carefully watching.Seems the glue did not stick to inner package.The surgery was delayed more than 30min due to this issue.
 
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Brand Name
CERAMIC FEMORAL HEAD
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
rachael wise
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key16263344
MDR Text Key308352430
Report Number3010536692-2023-00010
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/28/2023
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
Device Operator Other
Device Model Number26000013
Device Catalogue Number26000013
Device Lot Number1722921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/05/2023
Initial Date FDA Received01/30/2023
Supplement Dates Manufacturer Received01/05/2023
Supplement Dates FDA Received03/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient SexFemale
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