MAUDE Adverse Event Report: MicroPort Orthopedics Inc. PROFEMUR® NECK A/R VAR/VAL 1 SHORT COBALT CHROME; Hip Component

Model Number	PHAC1222
Medical Device Problem Codes	Corroded (1131); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient underwent a right total hip arthroplasty with a wright medical profemur® hip system.After years of satisfactory function, the patient began experiencing vibration, squeaking, and instability of the right hip while walking.Clinical evaluation revealed a broken and dislodged acetabular polyethylene liner, elevated cobalt and chromium levels, and corrosion at the modular neck-stem taper junction.During revision surgery, the surgeon confirmed gross corrosion of the profemur® plus cocr modular neck, black metal-stained synovial fluid, metallosis, adverse local tissue reaction, and failure of the acetabular polyethylene liner.The corrosion reportedly generated metal debris and metal ion release, resulting in surrounding tissue damage and necessitating revision of the femoral prosthesis and acetabular components.Products implanted from other company: stem and head.Mpo product implanted during revision surgery: micoport a-class 36mm poly liner.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® NECK A/R VAR/VAL 1 SHORT COBALT CHROME
• 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 ; +1(901)867-4771
• MDR Report Key: 50696368
• Report Number: 3010536692-2026-00466
• Device Sequence Number: 9614387
• Product Code: JDL
• UDI-Device Identifier: 00192629087293
• UDI-Public: 00192629087293
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Expiration Date: 07/31/2018
• Device Model Number: PHAC1222
• Device Catalogue Number: PHAC1222
• Device Lot Number: 070118227710
• 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: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• 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: Female