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

Model Number	PLS0R411
Medical Device Problem Codes	Difficult to Remove (1528); Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on or about april 30,204 patient had a profemur total hip system implanted in her right hip.On or about (b)(6) 2019 patient reported for revision surgery due to elevated cobal and chromiun levels, pain and evidence of a pseudotumor.Patient's first revision was necessary because the device failed due to corrosion at the neck-stem junction.It was discovered corrosion of the profemur cocr modular neck where it seated in the pocket of the modular stem.The implanted neck and head were revised.After the revision surgery patient reported at least 3 dislocations.The previous events were captured under microport orthopedics group number: 20060165.Additional information received (b)(6) 2022: allegedly, on or about (b)(6) 2021, patient reporter for a revision surgery of the right total hip arthroplasty, revision of both the acetabular and femoral components.Surgeon recommended this second revision surgery due to recurrent instability with dislocations.During revision surgery, surgeon determined the only way to safely remove the modular stem was to perform an extended trochanteric osteotomy(eto), which required four dall miles cables with the use of a 240 mm revision stem.First revision surgery was necessary due to the failure of the profemur total hip system causing metal wear debris and corrosion, elevated metals ions and pseudotumor, the need for second revision surgery, soft tissue damage and loss, along with weakening of the hip joint resulting in frequent dislocations and recurrent instability.It is important to realize that the stem, cup, and liner were implanted during patient's original surgery which occurred on (b)(6) 2014.These 3 components have been revised on (b)(6) 2021 along with the neck and head implanted on (b)(6) 2019.

• 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: 15583485
• Report Number: 3010536692-2022-00357
• Device Sequence Number: 6470813
• Product Code: JDL
• UDI-Device Identifier: M684PLS0R4111
• UDI-Public: M684PLS0R4111
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• 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): 10/11/2022

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: Health Professional
• Device Model Number: PLS0R411
• Device Catalogue Number: PLS0R411
• Device Lot Number: 1528012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/21/2022
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 10/11/2022
• 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 Age: 86 YR
• Patient Sex: Female