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

Model Number 38AM4604

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Event 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
• 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: 15316449
• MDR Text Key: 298870615
• Report Number: 3010536692-2022-00301
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M68438AM46041
• UDI-Public: M68438AM46041
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/29/2022
• 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