MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 44MM; HIP COMPONENT

Model Number	38AM4404
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on (b)(6) 2008, plaintif had a left hip implantation surgery.The wright medical hip components that were implanted included: a conserve plus cup cobalt-chromium cup (lot no.107476061); a profemur plasma z stem titanium stem (lot no.117488870); a profemur titanium neck (lot no.107484845); and, a conserve total a-class head cobalt-chromium head (lot no.087466397).On (b)(6) 2009 plaintiff underwent a revision surgery, in this surgery, the conserve plus cup was removed and replaced with a wright medical dynasty cup; the conserve total a-class headcobalt-chromium head was removed and replaced with a conserve a-class head cobalt-chromium head.On (b)(6) 2021, plaintiff had a revision surgery performed on his left hip.Dr.(b)(6) noted a massive pseudotumor and related it to metallosis.Dr.(b)(6) , removed the wright medical components from plaintiff, revision surgery operative notes that the surgery took double the amount of time of normal revision hip replacement.Involved pseudotumor debridement and extensive exposure for stem removal.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 44MM
• 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: 14376687
• Report Number: 3010536692-2022-00187
• Device Sequence Number: 5653856
• Product Code: KWA
• UDI-Device Identifier: M68438AM44041
• UDI-Public: M68438AM44041
• 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: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: Health Professional
• Device Model Number: 38AM4404
• Device Catalogue Number: 38AM4404
• Device Lot Number: 068619018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/12/2022
• 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: Male