FX V135
Received Jul 31, 2026 · Event occurred Jul 15, 2026
Report 3014128390-2026-00037 · MDR key 50105806
Device
Generic name
Reverse Shoulder Prosthesis
Manufacturer
Fx Shoulder Solutions DallasCatalog number
318-5208
Lot number
W2217
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Medical device site infection
Narrative
Description of Event or Problem
Revision occurred on (b)(6) 2026 approximately 27 days after the primary surgery which happened on (b)(6) 2026. No fall or other trauma reported. Based on comparing usage forms FX V135® HUMELOCK STEM TA6V Ø32/08 L. 120MM CEMENTLESS Ti/HA and FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +6 was explanted due to infection and replaced with FX V135® HUMELOCK STEM TA6V Ø32/08 L. 120MM CEMENTLESS Ti/HA and FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +6.
Additional Manufacturer Narrative
Revision occurred approximately 27 days after the primary surgery due to infection. No actual, implied or suspect link to FX product.