MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 50MM SHORT NECK; HIP COMPONENT

Model Number	38015004
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was diagnosed on 2006 with vascular necrosis of the femoral head on his right hip.On (b)(6) 2006 patient undergo right total hip arthroplasty with wright products in (b)(6) barcelona.After his right total hip arthroplasty, patient suffered from progressive coxalgia, which resulted in cessation of the march and reduced capability to wander as well as articular and periarticular inflammation.Patient had a series of medical examinations on (b)(6) 2019 and (b)(6) 2019 which confirmed the existence of a 97 mm pseudotumor which produced a cystic lesion in the cortical area of the ischial tuberosity and the insertion of the gluteal muscles, with atrophy and fat substitution of the gluteus medius and minor, the cause being an inflammatory reaction due to metallosis, that is, a corrosion of the components manufactured by wright.On (b)(6) 2019, the patient underwent a blood test that confirmed the presence of chromium and cobalt in the blood, being visited urgently by dr.Belloti and confirming the existence of a local reaction due to periprosthetic metallosis in the right hip, establishing prosthetic replacement of the right hip once a period of at least 3 months had passed after a vascular surgery that the patient had recently undergone in (b)(6) 2019.The patient was finally operated on again on (b)(6) 2021, carrying out a replacement of the total right hip prosthesis with extraction of the pseudotumor and complete cleaning of the osteoloses, being discharged from the hospital on (b)(6) 2021.Based on the foregoing, the patient suffered a dislocation of the prosthetic joint caused by a distorting trauma to the lower right extremity, performing surgery on april 1 of the same year for a new replacement of the hip prosthesis, debridement of soft tissues, open reduction of the implant and reconstruction of gluteus maximus and medius tendon plasty transfer, currently undergoing rehabilitation and recovery treatment.Notwithstanding this, it should be noted that on (b)(6) 2021, the patient proceeded to undergo a new blood test that confirmed the substantial decrease in the hematological presence of cobalt and chromium.

• Brand Name: CONSERVE® BFH® HEAD 50MM SHORT 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: 15267242
• Report Number: 3010536692-2022-00296
• Device Sequence Number: 6475511
• Product Code: KWA
• UDI-Device Identifier: M684380150041
• UDI-Public: M684380150041
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• 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): 08/22/2022

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: 38015004
• Device Catalogue Number: 38015004
• Device Lot Number: 095275498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/22/2022
• 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