MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z CLASSIC STEM SZ 5 STRAIGHT SHORT NECK; HIP COMPONENT

Model Number	PHA0CLS5
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
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, patient underwent thr on (b)(6) 2015 left hip revised on (b)(6) 2019 due multiple hip dislocation.The femoral stem originally used was a profemur z classic size 5 short straight neck and femoral head was a biolox delta 28mm s, double mobility polyethylene liner was used.Only the femoral head and liner were revised there is no further data on what devices were implanted after revision surgery.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Review of the complaint does not reveal any failure involving this implant.These implants were not returned for investigation, nor were any pictures provided to assist with the investigation.These implants were implanted for approximately 43 months before being revised due to hip dislocation.In the revision surgery, pha04402 and dlxpxb28 were revised while pha0cls5 were not.It is unknown when this implant was manufactured or if it was manufactured to specification due to the unknown lot number.There are no trends for this implant and failure.It cannot be concluded what the level of contribution, if any, that the product had to the complaint.No further evaluations can be made without return of the product or receipt of additional clinical information.The mpo hip systems package insert (150803-9) lists dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity? as a potential adverse effect of total hip arthroplasty.Additionally, it also states periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.Periodic post-operative x-rays are recommended for close comparison with early post-op conditions to detect long term evidence of changes in position, loosening, bending, or cracking of components.Mpo will continue to monitor this issue through complaint tracking.

• Brand Name: PROFEMUR® Z CLASSIC STEM SZ 5 STRAIGHT SHORT NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 21316036
• Report Number: 3010536692-2025-00030
• Device Sequence Number: 15566359
• Product Code: JDI
• UDI-Device Identifier: M684PHA0CLS51
• UDI-Public: M684PHA0CLS51
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K123434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 12/08/2025

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: PHA0CLS5
• Device Catalogue Number: PHA0CLS5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 12/08/2025
• 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