MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION U2 BIPOLAR IMPLANT; Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Catalog Number	1503-3145
Medical Device Problem Codes	Device Slipped (1584); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation results indicated that the in-process inspections and records for this unit complied with all specifications.A correlation between the reported event and this medical device cannot be confirmed.However, given that the use of this product cannot be entirely ruled out as a potential cause or contributing factor to the event, this report is submitted in accordance with relevant regulatory requirements.
Event or Problem Description
A patient underwent a bipolar hip implantation surgery on (b)(6) 2017.The patient experienced discomfort while bending down to sit, and x-rays revealed a dissociation between the acetabular cup and the femoral head.A revision surgery was performed on the same day (b)(6) 2017 to replace the implants with a new u2 bipolar implant and femoral head.

• Brand Name: U2 BIPOLAR IMPLANT
• Common Device Name: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; hsinchu city, taiwan; hsinchu, ; TW
• Manufacturer (Section G): UNITED ORTHOPEDIC CORPORATION; hsinchu city, taiwan; hsinchu city, ; TW
• Manufacturer Contact: lois ho ; united orthopedic corporation / no 57, park ave 2,; science park, hsinchu city 30075, taiwan; hsinchu city, 30075
• MDR Report Key: 25038507
• Report Number: 9681642-2026-00006
• Device Sequence Number: 18744713
• Product Code: KWY
• UDI-Device Identifier: 04712771493979
• UDI-Public: 04712771493979
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K152439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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 Catalogue Number: 1503-3145
• Device Lot Number: 17E555D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female