MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ACETABULAR CUP; HIP COMPONENT

Model Number	PHA06220
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when the investigation is complete.
Event or Problem Description
(b)(4).Allegedly, revision surgery of the left hip due to early procotyl l cup loosening and migration.Removal of loosed acetabular component (procotyl l), threaded cup implantation, replacement of modular neck and head (due to infection risk reduction).
Additional Manufacturer Narrative
Update initial reporter information.
Event or Problem Description
(b)(4).Allegedly, revision surgery of the left hip due to early procotyl l cup loosening and migration.Removal of loosed acetabular component (procotyl l), threaded cup implantation, replacement of modular neck and head (due to infection risk reduction).Additional information received on 10/09/2020 from clinical department : adding lot numbers of the products , updating customer and doctor information.
Additional Manufacturer Narrative
Additional information was received on 10/09/2020, updated patient age, incident description, lot number, initial reporter information and investigation codes.

• Brand Name: ACETABULAR CUP
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9365819
• Report Number: 3010536692-2019-01152
• Device Sequence Number: 11304539
• Product Code: HWT
• UDI-Device Identifier: M684PHA062201
• UDI-Public: M684PHA062201
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2020

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: PHA06220
• Device Catalogue Number: PHA06220
• Device Lot Number: 1101243604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019; 10/25/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 03/20/2020; 12/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 102