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

Model Number	38AM5004
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, plaintiff had a wright medical hip system in the right hip, by the year 2021 plaintiff developed adverse symptoms including, but not limited to, progressively worsening pain in and around his left and right hip joints, as well as neurologic symptoms including peripheral neuropathy, and tinnitus.Laboratory test results reported in (b)(6) 2021, revealed elevated serum chromium and blood cobalt levels in plaintiff.Dr.(b)(6) noted a pseudotumor and related it to metallosis.Remove the wright medical components, including the profemur® hip system, including the profemur® plus cocr modular neck and the profemur® plasma z stem.Dr.(b)(6) also informed plaintiff that it would be medically necessary to remove and replace the conserve® femoral head and dynasty cup.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 50MM
• 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: 14375815
• Report Number: 3010536692-2022-00185
• Device Sequence Number: 12172578
• Product Code: KWA
• UDI-Device Identifier: M68438AM50041
• UDI-Public: M68438AM50041
• 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: 2007
• 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): 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: 38AM5004
• Device Catalogue Number: 38AM5004
• Device Lot Number: 087466397
• 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