MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 3.5CM LEN; KNEE COMPONENT

Model Number 18080304

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly, periprosthetic fracture of the acetabular component patient was seen in clinic post sx between jul 2012-jan 2013 improvements was slow pt was not fully weight beaning.Pt ended up having a failed acetabular on (b)(6) 2013, the patient underwent a revision with cage reconstruction.

Event Description

Allegedly the patient was revised due to multiple hip dislocations, having a failed acetabular.(right) additional information received on (b)(6) 2019: (b)(4) 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.

Manufacturer Narrative

Updated description, initial reporter, event and evaluation codes.This event was reported under 3010536692-2016-00812, 3010536692-2016-00813, 3010536692-2016-00767 and 3010536692-2020-00386.This is an additional component associated to the event.

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 3.5CM LEN
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9199994
• MDR Text Key: 162566958
• Report Number: 3010536692-2019-01097
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: M684180803041
• UDI-Public: M684180803041
• Combination Product (y/n): N
• PMA/PMN Number: K864626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 18080304
• Device Catalogue Number: 18080304
• Device Lot Number: 089912721
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2019
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 09/16/2019; 09/16/2019
• Supplement Dates FDA Received: 06/04/2020; 02/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 29