MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 2.0CM LEN; KNEE COMPONENT

Model Number	18080301
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.

• Brand Name: CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 2.0CM LEN
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9100713
• Report Number: 3010536692-2019-01047
• Device Sequence Number: 19488790
• Product Code: HWC
• UDI-Device Identifier: M684180803011
• UDI-Public: M684180803011
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K864626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 18080301
• Device Catalogue Number: 18080301
• Device Lot Number: 1686654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 01/31/2020
• Patient Sequence Number: 1