inforMED
InjuryMBH

Persona All Poly Patella 29mm

Received Jul 28, 2026 · Event occurred Jul 7, 2026

Report 0002648920-2026-00135 · MDR key 50053725

Device

Generic name

Prosthesis, Knee

Model number

N/A

Catalog number

42540000029

Lot number

66589473

Product problems

  • Positioning Problem
  • Loosening of Implant Not Related to Bone-Ingrowth

Patient

Not reported

  • Pain
  • Joint Laxity
  • Swelling/ Edema
  • Radiolucent Lines
  • Aseptic loosening

Narrative

Description of Event or Problem

It was reported that the patient is tentatively awaiting a left knee arthroplasty revision to address tibial component loosening, pain, swelling and instability after a fall.Initial operative notes noted no intraoperative complications.Attempts have been made and no further information has been provided.

Additional Manufacturer Narrative

(b)(4).D10 - Concomitant Devices - Persona Tibial Component Size D Left Catalog #: 42536006701 Lot #: 66523653, Persona CPS Articular Surface Left 3-5 CD Catalog #: 42512600410 Lot #: 66079892, Persona PS Cemented Femoral Component Size 5 Left Catalog #: 42500605801 Lot #: 66297433.The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental MedWatch 3500A will be submitted.