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

Model Number	PHAC1212
Medical Device Problem Codes	Corroded (1131); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)
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, a patient with bmi over 40 and has advised legal that brought surgeon to follow up with hospital.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.From correspondence with an mpo employee who communicated with a surgeon involved with this event, the patient was stated to have been experiencing pain.The pain is possibly believed to be associated with an adverse reaction to the cocr modular neck as it was reported that bone and tissue were removed that indicated an adverse reaction.The revised products have not been returned to mpo for investigation.Additionally, mpo has not received any radiographs, images of the explanted devices, operative notes, or other support clinical documentation to confirm the alleged complaint.The provided information does note that the patient is tall and has a bmi of 40.Review of the device history record (dhr) for the subject manufacturing lot indicates that this part was manufactured to specification.Furthermore, mpo has not received any other complaint reports for the subject manufacturing lots.The potential for adverse reaction to a cocr modular neck is an issue addressed by corrective and preventive action (capa).This capa found that, "the potential for a patient reaction when implanted with a profemur® cocr modular neck is a known risk for this product technology.A combination of patient and surgical factors can contribute to an elevated risk of an adverse patient reaction.These factors include, but are not limited to, patient sensitivity, surgical technique, patient weight and activity level." additionally, the microport hip systems package insert lists "allergic reactions to materials; metal sensitivity; or reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval)" as possible adverse effects associated with total hip arthroplasty.No conclusions regarding potential product contribution to the alleged complications can be determined from the available information.There were not any trends identified for this device and complaint type at the time of this complaint.Mpo will continue to monitor this complaint through complaint tracking.Updated investigation after new information received: wm 3/17/2026 the alleged complaint could not be confirmed.This investigation is being updated after receiving a legal file associated with this incident.The previous investigation was completed using information reported by an mpo employee who received information from a surgeon.Review of the provided legal file alleges that a revision operation was required due to corrosion at the neck-stem junction of the construct.The revision operation took place approximately 104 months after the index operation.Regarding the details outlined in the newly received file, the investigation findings from the initial investigation remain valid as follows: "the revised products have not been returned to mpo for investigation.Additionally, mpo has not received any radiographs, images of the explanted devices, operative notes, or other supporting clinical documentation to confirm the alleged complaint.The provided information does note that the patient is tall and has a bmi of 40.Review of the device history record (dhr) for the subject manufacturing lot indicates that this part was manufactured to specification.Furthermore, mpo has not received any other complaint reports for the subject manufacturing lots.The potential for adverse reaction to a cocr modular neck is an issue addressed by corrective and preventive action (capa).This capa found that, 'the potential for a patient reaction when implanted with a profemur® cocr modular neck is a known risk for this product technology.A combination of patient and surgical factors can contribute to an elevated risk of an adverse patient reaction.These factors include, but are not limited to, patient sensitivity, surgical technique, patient weight and activity level.' additionally, the microport hip systems package insert lists 'allergic reactions to materials; metal sensitivity; or reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval) as possible adverse effects associated with total hip arthroplasty.No conclusions regarding potential product contribution to the alleged complications can be determined from the available information.There were not any trends identified for this device and complaint type at the time of this complaint.Mpo will continue to monitor this complaint through complaint tracking.".
Event or Problem Description
Allegedly, a patient with bmi over 40 and has advised legal that brought surgeon to follow up with hospital.Additional information received on 09-19-2025: the patient was experiencing pain, possibly from metal reaction between cocr modular neck and femoral stem.It was reported that bone and tissue was removed during the revision with visible evidence of a reaction.The cocr neck was replaced with a titanium modular neck.Additional information received on 01-27-2026: revision surgery was necessary due to corrosion at the neck-stem junction of the device.Medical records indicate, among other things: dark grey to black residue on the femoral neck component from that junction into the femoral stem; metallosis with soft tissue erosion; and tendon repairs related to tissue necrosis and pseudotumor formation.

• Brand Name: PROFEMUR®
• 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: 22935258
• Report Number: 3010536692-2025-00311
• Device Sequence Number: 9864948
• Product Code: MBL
• UDI-Device Identifier: M684PHAC12121
• UDI-Public: M684PHAC12121
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026

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: PHAC1212
• Device Catalogue Number: PHAC1212
• Device Lot Number: 1677589
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/10/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male