MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM SZ 1; HIP COMPONENT

Model Number	PRTL0021
Medical Device Problem Codes	Corroded (1131); Material Frayed (1262)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Metal Related Pathology (4530)
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, on (b)(6) 2010 patient had a wright medical artificial hip implanted in the right side of her body in a procedure known as a total hip arthroplasty (tha).Patient's orthopedic surgeon in the year 2021, informed patient that in his medical judgment it was advisable to undergo a right hip revision surgery to remove the profemur hip system including the profemur plus cocr modular neck and the profemur tl femoral stem and replace it with a hip stem system of a different medical device manufacturer.On (b)(6) 2021 patient had a revision surgery performed on her right hip.Due to micromotion and fretting corrosion of the oblong taper of the profemu plus cocr modular neck where it seated in the pocket of the stem, the profemur plus cocr modular neck implanted in patient's right hip corroded causing physical injury to patient.Patient sustained injuries and damages including but not limited to pain, suffering disability, and physical impairment.It is stated that patient's profemur plus cocr modular neck suffered micromotion, fretting corrosion, galvanic corrosion, and fracture.It is also stated that patient suffered serious and permanent physical injuries to bone, muscle, tendons, tissues and nerves in her hip and pelvis.An invoice for the initial surgery performed on (b)(6) 2010 is found.The lot number for the poly liner and the dynasty pc shell stated on the legal file differ from the lot number in the invoice.Part number and lot number for the neck and stem stated on the legal file differ from the part number and lot number of the invoice.Part number and lot number for the head and screw stated on the legal file are the same part number and lot number in the invoice.

• Brand Name: PROFEMUR® TL STEM SZ 1
• 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: 15544764
• Report Number: 3010536692-2022-00354
• Device Sequence Number: 17785783
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00211
• UDI-Public: M684PRTL00211
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K060358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 11/24/2022

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: PRTL0021
• Device Catalogue Number: PRTL0021
• Device Lot Number: 0501113748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/24/2022
• 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