The literature article entitled ¿humeral surface replacement for osteoarthritis¿ by tomas smith, andre gettmann, mathias wellmann, frederic pastor, and melena struck, published in acta orthopaedica june 26, 2013, was reviewed.The purpose of the article was to investigate the authors¿ hypothesis that preoperative flenoid wear and postoperative progress of glenoid erosion would influence the clinical outcome.61 resurfacing hemiarthroplasties (55 patients) for primary osteoarthritis.Six patients were lost to follow-up and five had undergone revision arthroplasty.This left 50 shoulders in 44 patients that were followed for a mean of 30 months.In the total population of 61 shoulders, the radiographs showed postoperative glenoid erosion in 38 cases and no humeral prosthetic loosening.Revision arthroplasty was performed in 11 cases after 28 months.The implant used was the global c.A.P.(depuy).Complications were: one intraoperative diaphyseal fracture of the humerus was treated by plate osteosynthesis.One deep hematoma developed and required revision surgery.One deep infection required revision surgery 20 days postoperatively without implant removal.Five cases of arthrofibrosis were noted and underwent arthroscopic capsular release with good functional results.Revision arthroplasty was performed in 11 cases, four of which were revised to reverse total shoulder arthroplasty were revised due to a rotator cuff tear, glenoid erosion, pain and/or infection.Radiographic results showed no sign of loosening at the time of final follow-up.Only one case showed superior migration of the humeral head after rotator cuff tear.No injury of neurovascular structures or gross malpositioning of the implants occurred.
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Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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