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

Model Number PHA06208

Device Problem Break (1069)

Patient Problem Unspecified Infection (1930)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, patient was ex domo (prof r implantation in another hospital).Prosthesis pseudo- arthritic, broken stem below proximal part.Regarding a low grade infect as differential diagnosis, stem and cup explanted in (b)(6) hospital.Bfarm case number: (b)(4).

• Brand Name: ACETABULAR CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 13638845
• MDR Text Key: 286424033
• Report Number: 3010536692-2022-00057
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA06208
• Device Catalogue Number: PHA06208
• Device Lot Number: 1629379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2022
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 85 KG