MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® R PROX BODY PLASMA SPRAY X-SMALL MODULAR; HIP COMPONENT

Model Number	PPW38354
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the profemur® total hip system implanted in plaintiff failed, and necessitated total revision surgery.About (b)(6) 2022, right hip was discovered to have failed, dr recommended the revision surgery after plaintiff presented with severe pain and lack of mobility and to remove the source of metallosis.

• Brand Name: PROFEMUR® R PROX BODY PLASMA SPRAY X-SMALL MODULAR
• 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: 16993489
• Report Number: 3010536692-2023-00095
• Device Sequence Number: 12529580
• Product Code: MRA
• UDI-Device Identifier: M684PPW383541
• UDI-Public: M684PPW383541
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K012091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 05/24/2023

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: Health Professional
• Device Model Number: PPW38354
• Device Catalogue Number: PPW38354
• Device Lot Number: 1562181
• 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: 05/02/2023
• Initial Report FDA Received Date: 05/24/2023
• 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