MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CERAMIC FEMORAL HEAD; HIP COMPONENT

Model Number 26000007

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, it was found that the trial neck and ball head prosthesis were stuck between them.Due to the patient's age and for the patient's postoperative rehabilitation, the director insisted on using the selected prosthesis, which took a long time to separate the prosthesis from the trial neck and finally failed, and had to choose a 32mm+0mm ball head prosthesis, which caused the surgery to be extended for one hour.(b)(4).

Manufacturer Narrative

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

• Brand Name: CERAMIC FEMORAL HEAD
• 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: 13154017
• MDR Text Key: 283234157
• Report Number: 3010536692-2022-00004
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030027
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26000007
• Device Catalogue Number: 26000007
• Device Lot Number: 1699584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2021
• Date Manufacturer Received: 12/15/2021
• 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: 76 YR
• Patient Sex: Female