MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 44MM MEDIUM NECK; HIP COMPONENT

Model Number 38014400

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problems Osteolysis (2377); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the plaintiff indicates that the hip had a unreasonably high risk of failing in her body, causing toxic levels of cobalt and chromic debris, tissue and bone destruction and the need for the plaintiff to undergo surgery to removed and replace the defective implant, on or about (b)(6) 2013 plaintiff's blood test showed that the hip has given her heavy metal poisoning.

Manufacturer Narrative

See investigation attach.

• Brand Name: CONSERVE® BFH® HEAD 44MM MEDIUM NECK
• 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: 13342147
• MDR Text Key: 284800543
• Report Number: 3010536692-2022-00015
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M684380144001
• UDI-Public: M684380144001
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021349
• 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: 01/31/2022

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: 38014400
• Device Catalogue Number: 38014400
• Device Lot Number: 107489019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2022
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/31/2022
• 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