MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 2.5CM LEN; KNEE COMPONENT

Model Number	18080302
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349); 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, periprosthetic fracture of the acetabular component patient was seen in clinic post sx between (b)(6) 2015 (b)(6) 2013 improvements was slow pt was not fully weight beaning.Pt endedup having a failed acetabular on (b)(6) 2013, the patient underwent a revision with cage reconstruction.
Additional Manufacturer Narrative
Updated description, initial reporter, event and evaluation codes.This event was reported under 3010536692-2016-00812, 3010536692-2016-00813, 3010536692-2016-00767, 3010536692-2020-00386 and 3010536692-2019-01097.This is an additional component associated to the event.
Event or Problem Description
Allegedly the patient was revised due to multiple hip dislocations, having a failed acetabular.(right) additional information received on (b)(6) 2019: sae# s050-003r001 allegedly, periprosthetic fracture of the acetabular component patient was seen in clinic post sx between (b)(6) 2013.Improvements were slow and the patient was not fully weight beaning.Patient was found to have a failed acetabular on (b)(6) 2013, and the patient underwent a revision with cage reconstruction.
Additional Manufacturer Narrative
Section h.6 code changed from medical code of dislocation to health code bone fracture.

• Brand Name: CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 2.5CM LEN
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9199991
• Report Number: 3010536692-2019-01098
• Device Sequence Number: 10865212
• Product Code: HWC
• UDI-Device Identifier: M684180803021
• UDI-Public: M684180803021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K864626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2021

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 Number: 18080302
• Device Catalogue Number: 18080302
• Device Lot Number: 0401114344
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019; 09/16/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 06/04/2020; 02/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 29