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

Model Number PHA01252

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Osteolysis (2377); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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
• Type of Device: 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
• MDR Text Key: 291462382
• Report Number: 3010536692-2022-00177
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012521
• UDI-Public: M684PHA012521
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male