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

Catalog Number	1503-3145 / 1503-3146
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	08/15/2017
Type of Reportable Event	Serious Injury
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 who underwent an initial surgery with u2 bipolar implant (45mm) on (b)(6) 2016; subsequently, a revision surgery was conducted with u2 bipolar implant (46mm) on (b)(6) 2017 due to the femoral head disassociated from the cap while the patient was sitting in a swivel chair.However, the disassociation occurred again during the patient walking, a re-revision surgery was conducted with u2 bipolar implant (45mm) on (b)(6) 2017.

• 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 city, ; TW
• Manufacturer (Section G): UNITED ORTHOPEDIC CORPORATION; no.57, park ave 2, science par; hsinchu city 30075, taiwan; hsinchu city, 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no.57, park ave 2, science park,; hsinchu city 30075, taiwan; hsinchu city, 30075
• MDR Report Key: 25038505
• Report Number: 9681642-2026-00007
• Device Sequence Number: 13364926
• 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
• 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
• Device Expiration Date: 08/09/2026
• Device Catalogue Number: 1503-3145 / 1503-3146
• Device Lot Number: 16G406C / 16F144A
• 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: 08/09/2016
• 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: 66 YR
• Patient Sex: Female