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); Loss of Range of Motion (2032)
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 profemur total hip system implanted on (b)(6) 2016 in her right hip, on (b)(6) 2021 plaintiff presented pain and lack of mobility, plaintiff needed a revision surgery because the device failed due to corrosion at the neck-stem junction of the device.At revision surgery, it was discovered that the device failed due to corrosion of the oblong taper of the profemur cocr modular neck where it seated in the pocket of the profemur.According to the information received in the report, we do not know if the screws, cup, liner and head were revised.

• 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 (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 14227344
• Report Number: 3010536692-2022-00149
• Device Sequence Number: 5232404
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12021
• UDI-Public: M684PHAC12021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 06/23/2022

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: 1634198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/23/2022
• 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: Unknown