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 Codes	Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on or about (b)(6) 2011 patient had a wright artificial hip implanted in his left hip, in a procedure known as a total hip arthroplasty ( or"tha").Following complaints of pain and physical limitations, patient reported for revision surgery of his left hip prosthesis.Patient's revision surgery was necessary due to pain caused by fretting and corrosion at the mixed metal junction at the cocr modular neck and titanium stem.In the course of the revision surgery surgeon removed patient's wright medical hip components on the left side, including the modular stem and neck.It was discovered that the profemur® cocr modular neck implanted in patient's left hip failed, meaning that due to corrosion of the oblong taper of the cocr modular neck where it seated in the pocket of the profemur® titanium stem it was causing physical injury to the patient.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• 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: 14978025
• Report Number: 3010536692-2022-00247
• Device Sequence Number: 17574843
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00261
• UDI-Public: M684PRTL00261
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 1001208934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/09/2022
• 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