MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION, U2 TOTAL KNEE SYSTEM; No Match

Catalog Number	2103-1260
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Defective Component (2292); Defective Device (2588); Naturally Worn (2988)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a tka surgery on (b)(6) 2021.A revision surgery was conducted on (b)(6) 2022 due to infection.The metal beads shedding of the porous femoral component was found during the revision surgery.
Additional Manufacturer Narrative
The root cause of this incident is likely related to poor coating sintering quality in a single workpiece.Traceability identified a total of (b)(4) units in the affected lot (lot no.20a286b).Of these, 13 units have been implanted in europe, while the remaining 3 units were returned to the manufacturer for analysis, with all results meeting specifications.Aside from the current case, no other abnormalities have been reported in the remaining implanted.

• Brand Name: U2 TOTAL KNEE SYSTEM
• Common Device Name: No Match
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION,; hsinchu city, taiwan; hsinchu, ; TW
• Manufacturer Contact: lois ho ; no 57, park ave 2, science park; hsinchu city 30075, taiwan; hsinchu city,
• MDR Report Key: 25038506
• Report Number: 9681642-2026-00010
• Device Sequence Number: 10411449
• Product Code: MBH
• UDI-Device Identifier: 04712602345477
• UDI-Public: 04712602345477
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140075
• 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: Recall
• 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: 2103-1260
• Device Lot Number: 20A286B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2020
• 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 Sex: Unknown
• Patient Weight: 120 KG