MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM SZ 6; HIP COMPONENT

Model Number	PRTL0026
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, following complaints of pain and physical limitations, patient reported for revision surgery of his left hip prothesis.Patient´s revision surgery was necessary due to pain caused by a failed metal on metal junction corrosion issue at the cocr modular neck and titanium stem.In the course of the revision surgery the surgeon removed patient?s wright medical hip components, including the modular neck and stem.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, following complaints of pain and physical limitations, patient reported for revision surgery of his left hip prothesis.Patient´s revision surgery was necessary due to pain caused by a failed metal on metal junction corrosion issue at the cocr modular neck and titanium stem.In the course of the revision surgery the surgeon removed patient?s wright medical hip components, including the modular neck and stem.

• Brand Name: PROFEMUR® TL STEM SZ 6
• 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: 13124946
• Report Number: 3010536692-2021-00618
• Device Sequence Number: 11203619
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00261
• UDI-Public: M684PRTL00261
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 03/02/2022

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: PRTL0026
• Device Catalogue Number: PRTL0026
• Device Lot Number: 0101006408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown