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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 1.5CM LEN; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 1.5CM LEN; KNEE COMPONENT Back to Search Results
Model Number 18080300
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly, patient presented with pain.Removal of dynasty cup for loosening.No acute injury of patient.Mpo implants were removed and replaced with another suppliers implants.
 
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Brand Name
CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 1.5CM LEN
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9100712
Report Number3010536692-2019-01046
Device Sequence Number2656249
Product Code HWC
UDI-Device IdentifierM684180803001
UDI-PublicM684180803001
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K864626
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/31/2020
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 Number18080300
Device Catalogue Number18080300
Device Lot Number1713309
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/21/2019
Initial Date Received by Manufacturer 08/21/2019
Supplement Date Received by Manufacturer08/21/2019
Initial Report FDA Received Date09/20/2019
Supplement Report FDA Received Date01/31/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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