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

Model Number	PHA00606
Medical Device Problem Codes	Unstable (1667); Migration (4003)
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) underwent re-revision surgery on (b)(6) 2020 due to migration of the prosthetic components from improper positioning and/or muscle and fibrous tissue laxity.No further information is provided.
Additional Manufacturer Narrative
The alleged complaint is not confirmed.Review of the complaint, (b)(4) lot w112382921435416 and (b)(4) lot 1440593, does not reveal any failure involving this implant.Mpo was made aware of this incident through a clinical study performed using mpo implants.These implants were not returned for investigation, nor were any pictures provided to assist with the investigation.These implants were implanted with (b)(4), and (b)(4), however, it was determined that this alleged implant failure was not related to these devices.Medical data was provided which listed implant information such as the lot numbers.It is unknown how long these implants were implanted for before being re revised due to migration of the components.These implants were manufactured in 2006 (b)(4) and 2012 (b)(4).Review of the design history records (dhr) for the subject manufacturing lots indicate that these implants were manufactured to specification.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 (b)(4) 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: 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: 21323959
• Report Number: 3010536692-2025-00034
• Device Sequence Number: 8603876
• Product Code: LPH
• UDI-Device Identifier: M684PHA006061
• UDI-Public: M684PHA006061
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K021346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/04/2025

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: PHA00606
• Device Catalogue Number: PHA00606
• Device Lot Number: W112382921435416
• 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: 12/04/2025
• 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