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

Model Number	PLS0R413
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on (b)(6) 2007, patient had a wright medical artificial hip implanted in the right side of his body in a procedure known as a total hip arthroplasty (tha).On (b)(6) 2021, patient's profemur hip suddenly structurally failed, breaking into two pieces at the oblong taper or distal end of the device, where it seated in the pocket of the profemur stem.The structural failure of the titanium profemur® modular neck component of patient's artificial hip was the result of a fatigue failure of the titanium, caused over time by cyclic loading of the device, until more than 90% of the distal end oblong taper had fractured through its cross section, and the remaining connected metal then suffered a tensile failure, resulting in a complete fracture of the modular neck.Because of the fracture of patient's profemur modular neck it was necessary for him to have emergency surgery performed to remove the failed device.On (b)(6) 2021, orthopedic surgeon, performed upon patient's hip a revision hip surgery, including an extended trochanteric osteotomy.Surgeon?s revision surgery included the removal from patient, all of the wright medical components of its right hip.Surgeon?s revision surgery included an extended trochanteric osteotomy to remove the otherwise well-fixed profemur renaissance stem, splitting the femur to remove the stem, and wiring the femur back together to hold the bone in place around the stem used in revision.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® RENAISSANCE® STEM
• 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: 15313434
• Report Number: 3010536692-2022-00299
• Device Sequence Number: 5467529
• Product Code: JDL
• UDI-Device Identifier: M684PLS0R4131
• UDI-Public: M684PLS0R4131
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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: PLS0R413
• Device Catalogue Number: PLS0R413
• Device Lot Number: 125220575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/29/2022
• 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