MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. BIPOLAR SHELL 42MM OD 28MM ID; HIP COMPONENT

Model Number 3110284200

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 10/18/2022

Event Type  Injury  

Event Description

Allegedly, trouble occurrence during bedside rehabilitation, an abnormality was noticed, and cup dislocation was confirmed by radiography.During the healing process, the neck was also dislocated, and the patient underwent revision.Doctor's finding: the patient originally had a standing acetabulum and problem was progressing, and while the dislocation was expected, the fact that the neck was dislocated was not.The patient requested an investigation.According to the x-rays, the neck and the stem were dislocated, this should not have happened, since these devices must be fixed, so it is presumed that these components were dissociated from each other.Japan (b)(4).

Manufacturer Narrative

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

• Brand Name: BIPOLAR SHELL 42MM OD 28MM ID
• 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: 15743668
• MDR Text Key: 303222533
• Report Number: 3010536692-2022-00401
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: M68431102842001
• UDI-Public: M68431102842001
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K861566
• 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: 02/08/2023

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: 3110284200
• Device Catalogue Number: 3110284200
• Device Lot Number: 1907850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2022
• Initial Date Manufacturer Received: 10/23/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 10/23/2022
• Supplement Dates FDA Received: 02/08/2023
• 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: 77 YR
• Patient Sex: Female