MalfunctionJWH
PERSONA FEM PS IMPACTOR PAD
Received Jul 31, 2026 · Event occurred Jul 8, 2026
Report 0001822565-2026-02724 · MDR key 50094561
Device
Generic name
Instrument, Knee
Manufacturer
Zimmer Biomet, Inc.Catalog number
42509909300
Lot number
62622551
Product problems
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that during an initial total knee arthroplasty, a piece of the femoral impactor pad fractured. No patient impact or adverse events have been reported as a result of the malfunction. All available information has been provided.
Additional Manufacturer Narrative
(b)(4)G2: Foreign - Event occurred in Canada.The customer has indicated that the product is in process of being returned to Zimmer Biomet for investigation. Once the investigation has been completed, a Follow-up MDR will be submitted.