Knee Instruments
Received Jul 27, 2026 · Event occurred Jul 15, 2026
Report 3005180920-2026-00767 · MDR key 50005837
Device
Generic name
Trial Insert Flex S4r - 11mm
Manufacturer
Medacta International SaModel number
11,01034Lot number
2520535
Product problems
- No Apparent Adverse Event
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
During trial insert placement, the locking feature of the insert trial became deformed, preventing proper engagement with the tibial plate.Multiple assembly attempts were unsuccessful despite cleaning of the surrounding tissues, adjustment of the leg position to improve surgical exposure, and anterior translation of the tibia to fully expose the tibial plate.Consequently, evaluation of the trial insert thickness during trial reduction was not possible, and a different-sized insert was subsequently used. The surgery was completed successfully. The total surgery time was 3 hours with a delay time of 30 minutes.
Additional Manufacturer Narrative
Batch review performed on 17 Jul 2026 Lot: 2520535: (b)(4) items manufactured and released on 07-Aug-2025. Expiration date: 2030-Jul-27. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review. Considering the semifinished lot: (MAT79547) of the device involved in this complaint, (b)(4) items were manufactured and released 07-May-2025. To date, no similar events have been reported on the same semifinished lot during the period of review. Considering the semifinished lot: (MAT81666) of the device involved in this complaint, (b)(4) items were manufactured and released 21-Jul-2025. To date, no similar events have been reported on the same semifinished lot during the period of review. Investigation performed by R&D Project Manager The images of the complaint show that the pegs of the trial insert used to connect to the base are bent. The reason for this complaint could be that, during the initial insertion, the baseplate & size 39;s connection features became slightly deformed or damaged, making clipping more difficult. To improve the baseplate-trial insert connection system, the baseplate design has been updated to ensure insert stability through the addition of lateral retaining walls, as is currently implemented in the metal instrumentation.