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

Model Number 26000009

Device Problems Separation Failure (2547); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Unequal Limb Length (4534)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the patient was revised due to leg length discrepancy of about 4mm on the right side.Radiographic images showed possible loosening of cup and stem.The revision was scheduled to replace the head and neck and possibly the liner.When trying to remove the neck from the stem, it could not be separated.So the stem was also removed.Additional information received on 02/02/2021: revised part and lot numbers were provided as well as the reason for revision, moreover the revision surgery date.

• 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: 11357861
• MDR Text Key: 232808612
• Report Number: 3010536692-2021-00096
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: M684260000091
• UDI-Public: M684260000091
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/21/2021

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: 26000009
• Device Catalogue Number: 26000009
• Device Lot Number: 094113340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention