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

Model Number	PHA01204
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, all components were removed from the femur.The canal was copiously irrigated.The final components were impacted into place.The hip was again relocated and noted to have excellent range of motion and excellent stability.66-year-old male with a history of a right total hip arthroplasty done in 2009 and previously well-functioning presented to my office earlier this week with 2 weeks of inability to bear weight and excruciating pain in the right hip.X-rays reveal a catastrophically failed right total hip arthroplasty with a fracture through the dual modular neck.X-rays reveal a catastrophically failed right total hip arthroplasty with a fracture through the dual modular neck.Patient had inflammatory markers as well as an aspiration that was nonconcerning for infection.We immediately encountered the broken neck segment as well as metallosis within the joint capsule.This was excised and debrided.Once we had adequate exposure of the broken head neck was removed.The acetabular component was inspected and found to be in good condition.A square tip impactor was used to check that the acetabular component was well ingrown, and it was.We then turned our attention to the femoral component.We exposed the proximal femur and the medial aspect of the neck of the component had catastrophically failed.There was fretting corrosion on both the broken neck segment as well as the proximal aspect of the stem.We used pencil-tip bur as well as a 6.5 mm bur to clear the shoulder as well as the interface between the bone and the implant.We had a good sense preoperatively that we were going to need to perform an extended trochanteric osteotomy to allow access to the stem which was obviously very well ingrown.We then were able to impact the stem in a retrograde fashion and after a prolonged period of working at the stem it was able to be removed.This was made very complex by the broken nature of the proximal aspect of the stem as well as the distorted anatomy.After the stem was removed, we then cleared the canal.There was a pedestal distally that needed to be cleared.He had excellent axial and rotational stability.We then turned our attention proximally where we put on a 65 mm lateral offset body and a +3.5 mm dual mobility head.This had excellent stability.We obtained intraoperative flatplate radiographs confirming appropriate implant position as well as leg length and offset.There was excellent stability of these components to 90 degrees of flexion 80 degrees of internal rotation.We applied the real 65 mm lateral offset body and used the torque limiting screwdriver after impacting it in place with the appropriate anteversion.We then placed the 50mm outer dual mobility head with a 28 mm +3.5 ceramic head.This was impacted in place.The hip was again reduced and taken through range of motion and found to be very stable.Because of the stability with our trials, we elected to leave the acetabular component in place given the morbidity of removing the component.Non-revised mpo products: part: 38025056 conserve® plus cup 50mm id 56mm od beaded, lot: 029796741, qty: 1.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 20727576
• Report Number: 3010536692-2024-00489
• Device Sequence Number: 8941289
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012041
• UDI-Public: M684PHA012041
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: PHA01204
• Device Catalogue Number: PHA01204
• Device Lot Number: 049812925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 08/01/2025
• 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 Age: 66 YR
• Patient Sex: Male