MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR FEMORAL NECK; HIP COMPONENT

Model Number	PHA01252
Health Effect - Clinical Codes	Osteolysis (2377); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, in the revision surgery the dr noted that there was a large soft tissue mass (pseudotumor) in the posterior aspect of the hip capsule and external rotators additional that there was a significant amount of metal-stained tissue involving synovium, capsule and bone in both, femur and acetabulum, that he removed an excessive amount of membranes, metallosis and osteolytic soft tissue.Because the hip stem was well fixed, an extended trochanteric osteotomy was required to remove the profemur® plasma z stem in plaintiff's left hip and removed all of the wright medical devices that had been implanted in plaintiff's left hip, except for the conserve® plus spiked cup, which was well fixed and left in place.In (b)(6) 2021 plaintiff developed adverse symptoms including, but not limited to, progressively worsening pain in and around his hip joints.In (b)(6) 2021 an mri demonstrated large fluid filled collections over both of plaintiff's hips.In (b)(6) 2021 laboratory tests also revealed that plaintiffs cobalt and chromium levels in his blood were significantly elevated.

• Brand Name: PROFEMUR® MODULAR FEMORAL 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: 14361749
• Report Number: 3010536692-2022-00177
• Device Sequence Number: 4819142
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012521
• UDI-Public: M684PHA012521
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: PHA01252
• Device Catalogue Number: PHA01252
• Device Lot Number: 0401108717
• 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
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 07/07/2022
• 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