MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK VAR/VAL 8DG SHORT COBALT CHROME; HIP COMPONENT

Model Number	PHAC1252
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); 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, on (b)(6) 2023 the patient visited a doctor because she was having pain.At that time she was diagnosed with a gluteus medius tendon tear.On (b)(6) 2023, the doctor informed her that the chromium level is 0.8, and her cobalt level is 2.7, above 1 ppb threshold.The doctor informed her that at this point in time, they will wait for her titanium level to come back.If her titanium level is above 10, this would be concerning for mechanically assisted crevice corrosion at the neck-stem taper junction.Over the next year it was determined that her cobalt and chromium levels were not stable.During the revision surgery the doctor found: failed right total hip arthroplasty; right hip, abductor tear and metal debris was noted at the stem-neck junction.Non mpo products: product id: 6230040e x3? liners/ lot no.: micrvn9/ qty: 1.Product id: 5000354e x3? stryker trident acetabular system/ lot no.: ni/ qty: 1.

• Brand Name: PROFEMUR® NECK VAR/VAL 8DG 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 ; 9018674771
• MDR Report Key: 21313992
• Report Number: 3010536692-2025-00025
• Device Sequence Number: 15474751
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12521
• UDI-Public: M684PHAC12521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• 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): 08/14/2025

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: PHAC1252
• Device Catalogue Number: PHAC1252
• Device Lot Number: 1451966
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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 Sex: Female