MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 48MM; HIP COMPONENT

Model Number 38AM4835

Device Problem Insufficient Information (3190)

Patient Problem Metal Related Pathology (4530)

Event Date 02/12/2024

Event Type  Injury  

Event Description

Allegedly, according to dr.Patient had metal allergy/high ion count believed to be from the existing metal head and metal conserve cup.Dr.Wanted to keep the stem,neck and cup; then replace the head with a delta option 28 and dynasty dual mobility 48mm poly liner.Dr.Understood that this was off-label.Dr thinks this would be least invasive option for patient.After relaying information that we at corporate, would not offer this implant, dr.Decided to remove entire stem after a gto.Implanted was a depuy corail stem and a stryker 48 dual mobility insert.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD LONG NECK 48MM
• 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: 18888348
• MDR Text Key: 337472395
• Report Number: 3010536692-2024-00131
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M68438AM48351
• UDI-Public: M68438AM48351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2024

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: Health Professional
• Device Model Number: 38AM4835
• Device Catalogue Number: 38AM4835
• Device Lot Number: 027405546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/12/2024
• 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 Age: 70 YR
• Patient Sex: Female