MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z CLASSIC STEM SIZE 4 STRAIGHT LONG NECK; HIP COMPONENT

Model Number	PHA0S238
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2020
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, the femoral head is opened behind and the no.4 prosthetic femoral stem is installed, during the installation process no.4 prosthetic femoral stem sinks easily, and it sinks more than the position when the medullary cavity file is used for the trial model, at this time the no.5 prosthetic femoral stem was opened and placed in the firm, the operation time was more expensive because of the no.4 handle.About 40 minutes more for elderly patients, there is a risk of complications in the prolonged anesthesia time.(b)(4).

• Brand Name: PROFEMUR® Z CLASSIC STEM SIZE 4 STRAIGHT LONG NECK
• 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: 13212436
• Report Number: 3010536692-2022-00010
• Device Sequence Number: 13829226
• Product Code: LPH
• UDI-Device Identifier: M684PHA0S2381
• UDI-Public: M684PHA0S2381
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 03/10/2022

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: PHA0S238
• Device Catalogue Number: PHA0S238
• Device Lot Number: 1778335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 03/10/2022
• 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: Male