MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. BIPOLAR ACETABULAR SHELL WITH DURAMER LINER; HIP COMPONENT

Model Number 3110284800

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, about 28 years ago, reporter is not sure which hospital, but a tha revision using a molar cup made by another company was performed because the perfecta stem bipolar cup inserted into the patient's body was experiencing dislocation due to polyethylene wear between the inner head and the cup.Japan (b)(4).

• Brand Name: BIPOLAR ACETABULAR SHELL WITH DURAMER LINER
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17938806
• MDR Text Key: 325719519
• Report Number: 3010536692-2023-00179
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K892398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 3110284800
• Device Catalogue Number: 3110284800
• Device Lot Number: 027477001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2023
• 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: 90 YR
• Patient Sex: Female