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	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.It is alleged that this patient was revised due to liner wear, disassociation, cup loosening, and metallosis from metal-on-metal contact between the femoral head and acetabular shell.The provided file specifically states, "an x-ray revealed marked superior migration of the femoral head in the acetabulum, some contact between the ball and the titanium shell, cup quite vertical and suspect loosening, cup migrated more vertical with risk of femoral head escaping, and with probably metal-on-metal." these products had been implanted for approximately 79 months at the time of revision.The revised products have not been returned to microport for investigation.No radiographs, images, or operative notes have been provided to confirm the alleged complications.Review of the device history record (dhr) for these lots indicates that these products met all established acceptance criteria throughout the manufacturing process.Review of historical complaint data reveals no other reported complaints involving these lots for the alleged complications.The microport hip systems package insert (150803-8) states, "periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.Periodic post-operative x-rays are recommended for close comparison with early post-op conditions to detect long term evidence of changes in position, loosening, bending, or cracking of components." this package insert also lists "dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity" and "?reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval) " as possible adverse effects of total hip arthroplasty.Furthermore, it states, "always follow the recommended surgical technique.Failure to adhere to the advised assembly instructions may have potential to increase risk of fretting corrosion, fatigue fracture or disassociation of the product.Prior to assembly, surgical debris and fluid must be cleaned from the interior of the female seat to ensure proper locking.Ensure components are firmly seated to prevent disassociation." no conclusions regarding this event can be made from the available information.There were no trends identified for the alleged complications per mpo trending procedures.This issue will continue to be monitored through complaint tracking.Methods: device not returned ((b)(4)).Device not accessible for testing ((b)(4)).Analysis of production records ((b)(4)).Trend analysis ((b)(4)).Results: no findings available ((b)(4)).Conclusions: device met specification.Device was used for treatment.Cause not established ((b)(4)).Known inherent risk of device ((b)(4)).This report was completed after 30 days of awareness as it was initially classified as not reportable due to human error.The error was detected during internal process controls.
Event or Problem Description
Allegedly, the patient was revised due to liner wear, disassociation, cup loosening, and metallosis from metal-on-metal contact with the femoral head and acetabular component.(right hip).

• 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: 12519946
• Report Number: 3010536692-2021-00525
• Device Sequence Number: 19948358
• Product Code: HWC
• UDI-Device Identifier: M684180803021
• UDI-Public: M684180803021
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K864626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: Health Professional
• Device Model Number: 18080302
• Device Catalogue Number: 18080302
• Device Lot Number: 1512697
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention