MalfunctionKWS
BASEPLATE/GLENOSPHERE INSERTER
Received Jun 22, 2026 · Event occurred May 27, 2026
Report 3002788818-2026-00083 · MDR key 25572865
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Ascension Orthopedics, Inc.Catalog number
INS-0990-861
Lot number
22MNC0006
Product problems
- Fracture
- Separation Failure
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A TSA SURGERY, AT THE MOMENT OF PLACING THE BASEPLATE/GLENOSPHERE INSERTER, WHEN SEPARATING THE INSTRUMENT FROM THE IMPLANT, THE SCREW DID NOT WANT TO RELEASE THE IMPLANT AND BROKE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE: (B)(4).