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

Model Number 26000004

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem Reaction (2414)

Event Date 02/13/2015

Event Type  Injury  

Manufacturer Narrative

The complaint will be updated once the investigation is completed.Trends will be evaluated.

Event Description

Allegedly the patient was revised due to a fractured liner, femoral head pseudo-tumor and metallosis (left).Subject presented at clinical follow-up on (b)(6) 2015 with implant cracking/clicking, as well a some calcification or ceramic debris on the x-ray.Subsequent clinical follow-ups indicated increasing squeaking/noises form hip.Subject presented to emergency (b)(6) 2017 with hip issues, and was scheduled for revision on (b)(6) 2017.Intraoperatively it was found the liner and femoral head were fractured and a small pseudo-tumor resulting from metallosis was present.Acetabular and femoral components were removed and revised.(b)(4).

• 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: 8629251
• MDR Text Key: 145684005
• Report Number: 3010536692-2019-00751
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26000004
• Device Catalogue Number: 26000004
• Device Lot Number: 1396895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/07/2019
• Date Manufacturer Received: 05/07/2019
• 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
• Patient Age: 35 YR
• Patient Weight: 73