MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L; HIP COMPONENT

Model Number PHA04418

Device Problems Break (1069); Corroded (1131)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, revision surgery was necessary because the device failed due to corrosion at the head-neck junction and neck-stem junction.The patient experience fracture at the stem and modular neck junction, metallosis, tissue reaction, pseudotumor, pain, loss of mobility and corrosion.

Manufacturer Narrative

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

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L
• 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: 19203377
• MDR Text Key: 341289501
• Report Number: 3010536692-2024-00280
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684PHA044181
• UDI-Public: M684PHA044181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130376
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA04418
• Device Catalogue Number: PHA04418
• Device Lot Number: 1814817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• 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 Sex: Female