MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. OMET TAPER COCR FEM HEAD 32MM +0MM NECK; HIP COMPONENT

Model Number	3611320000
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, cup, liner, head revised for recurrent dislocation.
Event or Problem Description
Allegedly, cup, liner, head revised for recurrent dislocation.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Review of the complaint, (b)(4) lot 455390, 3000xxxx lot unk, and x01532xx lot unk, does not reveal evidence of any failure involving these implants.These implants were not returned for investigation, nor was any pictures or additional medical documentation provided to assist in the investigation.(b)(4) lot 455390 was manufactured in 2007.Review of the design history record (dhr) for the subject manufacturing lot indicates that this implant was manufactured to specification.It is unknown when 3000xxxx and x01532xx were manufactured or if they were manufactured to specification due to the unknown lot number.There were no trends found for any of the implants in the complaint.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 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 for total hip arthroplasty implants.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.Methods: device not returned (4114).Trend analysis (4110).Analysis of production records (3331).Results: no findings available (3221).Conclusions: device met specification.Device was used for treatment.Cause not established (4315).Known inherent risk of device (22).

• Brand Name: OMET TAPER COCR FEM HEAD 32MM +0MM 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: 20314325
• Report Number: 3010536692-2024-00445
• Device Sequence Number: 7903148
• Product Code: LZO
• UDI-Device Identifier: M68436113200001
• UDI-Public: M68436113200001
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1995
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: Health Professional
• Device Model Number: 3611320000
• Device Catalogue Number: 3611320000
• Device Lot Number: 455390
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female