MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 46MM; HIP COMPONENT

Model Number	38AM4604
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on or around (b)(6), 2009, patient underwent a total hip arthroplasty (tha) on her left side at (b)(6).However, by the later part of the year 2020, patient's left hip had become painful.In early 2021, orthopedic surgeon informed her that he believed that her left hip had failed due to its metal-on-metal bearing surface and needed to be replaced.On (b)(6) 2021, patient's conserve® hip system was revised at (b)(6).During the revision of patient's hip, surgeon noted there was gross evidence of metallosis throughout the hip.Surgeon was able to explant the profemur tl stem without performing an extended trochanteric osteotomy.In the (b)(6), 2021, revision hip surgery, all of the wright medical hip devices that had been implanted on (b)(6), 2009, were removed and replaced with artificial hip devices manufactured by biomet-zimmer.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 46MM
• 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: 15316449
• Report Number: 3010536692-2022-00301
• Device Sequence Number: 5230195
• Product Code: KWA
• UDI-Device Identifier: M68438AM46041
• UDI-Public: M68438AM46041
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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: 38AM4604
• Device Catalogue Number: 38AM4604
• Device Lot Number: 049846059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/29/2022
• 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: Unknown