MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® RENAISSANCE® STEM; HIP COMPONENT

Model Number	PLS0R413
Medical Device Problem Codes	Corroded (1131); Material Frayed (1262); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
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, qs director received a call from a patient, for some reason patient has been experiencing pain.
Additional Manufacturer Narrative
Due to additional information received, it has been indicated that the product has not been revised, the incident is not related to a device failure.Please void this report.
Additional Manufacturer Narrative
Additional information was received, device failed due to corrosion at the neck-stem junction.
Event or Problem Description
Allegedly, qs director received a call from a patient, for some reason patient has been experiencing pain.Additional information on date 05/10/2023: allegedly, the patient has pain, and has been revised from the cocr neck to the ti neck.Patient stated had fretting, but her cocr levels were not too elevated based on what the doctor told.Additional information on date 08/23/2023: allegedly, device failed due to corrosion at the neck-stem junction.Revision could not be confirmed: part id: dspcgb48 dynasty® pc shell 48mm group b, lot: 1417042, qty: (b)(4).

• Brand Name: PROFEMUR® RENAISSANCE® STEM
• 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: 16644767
• Report Number: 3010536692-2023-00035
• Device Sequence Number: 3769762
• Product Code: LPH
• UDI-Device Identifier: M684PLS0R4131
• UDI-Public: M684PLS0R4131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 11/18/2023
• 2 Devices were Involved in the Event: 1 2

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: PLS0R413
• Device Catalogue Number: PLS0R413
• Device Lot Number: 1550698
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 02/28/2023; 02/28/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/28/2023; 07/27/2023; 11/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female