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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 4.0CM LEN; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 4.0CM LEN; KNEE COMPONENT Back to Search Results
Model Number 18080305
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly the patient has dislocated 3 times, (b)(6) pa.The above implants were removed from the patient and replaced with strykers.Strykers dual mobility was used with a 28mm + 7mm head of ours.
 
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Brand Name
CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 4.0CM LEN
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8865590
Report Number3010536692-2019-00994
Device Sequence Number16800514
Product Code HWC
UDI-Device IdentifierM684180803051
UDI-PublicM684180803051
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K864626
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/06/2019
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 Health Professional
Device Model Number18080305
Device Catalogue Number18080305
Device Lot Number0901207842
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/08/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/08/2019
Initial Report FDA Received Date08/06/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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