Product complaint #: (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
Article entitled short-term results of a new anatomic stemless shoulder arthroplasty - a prospective multicentre study written by tomas smith, hauke horstmann, roman karkosch, spiros tsamassiotis, nina bowsher, alexander ellwein, and marc-frederic pastor published in orthopedic reviews in 2022 was reviewed.The aim of this prospective multicentre study was to determine the short-term clinical and radiologic outcome of a new stemless design.154 shoulders were involved in the study.All were implanted with the global icon humeral component, global anchor peg glenoid, and humeral head.Adverse events: radiographic images indicated one shoulder had osteolysis.No treatment indicated.Three glenoid fractures post-op -no treatment indicated.Two proximal humerus fracture post op ¿ no treatment indicated.One shoulder with radiographic loosening of the glenoid component with no revision yet performed.One shoulder with intra-op proximal humeral fracture.No treatment indicated.One shoulder sustained a subscapularis tear, and an exchange of the prosthetic humeral head and subscapularis repair was performed 8 months after surgery.10 shoulders sustained pain/discomfort with no treatment indicated.3 shoulders with tendonitis and other tendon disorders with no treatment indicated.3 shoulders with rash and other skin disorders with no treatment indicated.3 shoulders with hematoma with no treatment indicated.2 shoulders with dorsal subluxation with no treatment indicated.2 shoulders with bursitis with no treatment indicated.2 shoulders with rotator cuff syndrome with no treatment indicated.2 patients with neuralgia/paresthesia with no treatment indicated.1 patient with stiffness with no treatment indicated.1 patient with periarthritis with no treatment indicated.1 patient who sustained a fall with breast swelling.No treatment indicated.
|