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

Model Number	38014400
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Reaction (2414); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See investigation attached.
Event or Problem Description
Allegedly, patient was revised due to metal on metal complications.
Additional Manufacturer Narrative
Updated initial reporter information.
Additional Manufacturer Narrative
Section b.5 :additional information in description / section f.6: awareness date update/ section h.6 health effect and medical device code added.
Event or Problem Description
Allegedly, patient was revised due to metal on metal complications (left hip).Additional information received on 7/25/2022: allegedly, on (b)(6) 2007 patient was admitted to the hospital of piombino.Diagnosed with left coxarthrosis to undergo surgery on (b)(6) 2007 for total left hip replacement.Discharged on (b)(6) 2007.After a few years, and more precisely at the end of 2015 - beginning of 2016, the patient started to complain of pain in her left hip which did not allow her to walk properly.Patient underwent an orthopedic examination which revealed an important presence in the blood of metallosis, with high concentrations of cobalt and chromium and related intoxication, and moreover, the same problem for which she had been operated had recurred, namely coxalgia.The same prosthesis presented serious wear, from which the metallosis in the blood with consequent physical damage and disability of patient.Patient was again hospitalized, for the reasons mentioned above, at the cecina hospital, on (b)(6) 2018, to undergo a new one prosthesis replacement surgery.Examination from dr.Vanni found that hip arthroplasty surgery left, with "mom" prosthesis implant made on (b)(6) 2007 at the ou orthopedics and traumatology of piombino, caused, given the characteristics of the prosthesis, the release of heavy metals (metallosis from chromium and cobalt), with a consequent increase of the same in the blood and urinary levels of the actress and onset of important joint synovial reaction, responsible for subsequent mobilization of the prosthetic component, hence the need for replacement / revision surgery of prosthetics in 2018, after which the levels of metals in the blood of today's actress so they had significantly decreased.The aforementioned coroner also points out that the causal link between arthroplasty and the metallosis is further strengthened by the finding of a reduction in blood levels of chromium and cobalt (in the face of an increase in urinary levels) after surgery revision of the prosthesis.

• 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: 9939144
• Report Number: 3010536692-2020-00330
• Device Sequence Number: 3293075
• Product Code: KWA
• UDI-Device Identifier: M684380144001
• UDI-Public: M684380144001
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2022

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: 116392084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 03/16/2020; 03/16/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/17/2020; 09/12/2022
• 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