MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 54MM LONG NECK; HIP COMPONENT

Model Number	38015435
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	01/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly the patient report "clicking and popping" sounds from his right hip, the dr noted audible and palpable popping of the right hip with flexion, and the radiographic images revealed that the wright medical conserve hip failed and the patient was suffering from elevated cobalt chrome levels.

• Brand Name: CONSERVE® BFH® HEAD 54MM LONG 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: 14690688
• Report Number: 3010536692-2022-00217
• Device Sequence Number: 17474522
• Product Code: KXA
• UDI-Device Identifier: M684380154351
• UDI-Public: M684380154351
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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: Health Professional
• Device Model Number: 38015435
• Device Catalogue Number: 38015435
• Device Lot Number: 04480126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/14/2022
• 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: Male