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 Code	Insufficient Information (4580)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent a left-sided total hip arthroplasty on (b)(6) 2020.On or about (b)(6) 2024, the patient reported to the surgeon pain, debilitating lack of mobility, and he recommend revision surgery because the device failed due to corrosion at the neck-stem junction.The modular neck slot and femoral neck distal end has corrosive changes and metal debris consistent with cocr damage.Non revised products: product id: p2lxsd36 prime a-class® xlpe standard / lot no.: 1835920 / qty: 1.Product id: p3sbqd54 prime biofoam quad shell / lot no.: 1834699 / qty: 1.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• 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: 19559348
• Report Number: 3010536692-2024-00347
• Device Sequence Number: 11945736
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12521
• UDI-Public: M684PHAC12521
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: 1838673
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 11/14/2024
• 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