MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. STEM REVISION; HIP COMPONENT

Model Number	PHA00612
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
Clinical study # (b)(4).Patient # (b)(6) reported the following adverse event: hip dislocation.Dislocation was treated with close reduction.This adverse event did not end in re-revision surgery.No further information is provided due to privacy policies.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Mpo was made aware of this incident through a clinical study performed using mpo implants.It is unknown when this incident occurred or how long the implants were implanted prior to the incident.These implants were not returned for investigation, nor were any pictures provided to assist with the investigation.Medical data was provided which listed implant information such as the lot numbers.These implants were manufactured in 2007 (pha00612 and pha02858), 2008 (pha03858), 2010 (pha04410), and 2011 (pha01232).Review of the design history records (dhr) for the subject manufacturing lots indicate that these implants were manufactured to specification.It cannot be concluded what 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 other 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 xrays 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: STEM REVISION
• 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: 21323617
• Report Number: 3010536692-2025-00032
• Device Sequence Number: 12794248
• Product Code: LPH
• UDI-Device Identifier: M684PHA006121
• UDI-Public: M684PHA006121
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K021346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/05/2025

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: PHA00612
• Device Catalogue Number: PHA00612
• Device Lot Number: 058479045
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown