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

Model Number	38014400
Health Effect - Clinical Codes	Osteolysis (2377); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem 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.
Additional Manufacturer Narrative
See investigation attach.

• Brand Name: CONSERVE® BFH® HEAD 44MM MEDIUM NECK
• Common Device Name: 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
• Report Number: 3010536692-2022-00015
• Device Sequence Number: 3897721
• Product Code: KWA
• UDI-Device Identifier: M684380144001
• UDI-Public: M684380144001
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female