MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK NEUTRAL SHORT COBALT CHROME; HIP COMPONENT

Model Number	PHAC1202
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, plaintiff underwent a right-sided revision of the acetabular liner/femoral head and neck.The profemur total hip system has failed due to corrosion related adverse tissue reactions and the device has been surgically removed, plaintiff presented pain and disassociation of the acetabular poluethylene component without dislocation, modular head (phac1202) and cobalt chrome head (26000025) were implanted.Products not revised: product id: 18080303, cancellous self-tapping 6.5mm bone screw 3.0cm length, lot: 1558083, qty: 1 product id: ppw38372, profemur® 115mm straight fully coated cyl/ps sz 12, lot: 1571390, qty: 1 product id: ppw38354, "profemur® r" prox body plasma spray x-small modular lot: 1562181, qty: 1 product id: dsbfge54, dynasty® bf shell 54mm group e lot: 1565510, qty: 1 product id: 18080303, cancellous self-tapping 6.5mm bone screw 3.0cm length lot: 1558084, qty: 1.

• Brand Name: PROFEMUR® NECK NEUTRAL 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: 16768405
• Report Number: 3010536692-2023-00087
• Device Sequence Number: 14237786
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12021
• UDI-Public: M684PHAC12021
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: PHAC1202
• Device Catalogue Number: PHAC1202
• Device Lot Number: 1555643
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/19/2023
• 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