The literature article titled, "outcomes of an anatomic total shoulder arthroplasty with a contralateral reverse total shoulder arthroplasty" written by ryan m.Cox, bs, eric m.Padegimas, md, joseph a.Abboud, md, charles l.Getz, md, mark d.Lazarus, md, matthew l.Ramsey, md, gerald r.Williams jr, md, and john g.Horneff iii, md published by elsevier journal of shoulder and elbow surgery 2018 was reviewed.The article's purpose was to compare outcomes of patients with a tsa (total shoulder arthroplasty) verse rsa (reverse shoulder arthroplasty) in the contralateral shoulder.Data was initially compiled from 24 patients and filtered to a final 19 patients (9 in tsa group and 10 in rsa group) who received implants from 2004 to 2015.Depuy products and non depuy products were utilized in both tsa and rsa group.Depuy global ap system was listed among the tsa group and depuy delta xtend was listed among the rsa group.Cement manufacturer is not identified.Article reports 3 of the 5 patient excluded from initial data set required revision arthroplasty all in tsa group for periprosthetic infection (1), subscapularis rupture (1) and rotator cuff tear (1).In the final data set, complications were noted in each group captured in this complaint.Tsa group depuy products: global ap humeral stem, global ap humeral head, global ap glenoid rsa group depuy products: delta xtend humeral stem, delta xtend humeral cup, delta xtend glenosphere, delta xtend metaglene, delta xtend non locking screws (2), delta xtend locking screws (2).Total adverse events: infection (treated by revision) - tsa group, subscapularis rupture (treated by revision) - tsa group, rotator cuff tear (treated by revision) and one untreated (patient elected no revision surgery)- tsa group, periprosthetic type b fracture (treated nonoperatively, no further information provided regarding anatomical location) - in tsa group, acromial stress fracture 3 months post op (no further information regarding treatment) - in rsa group, deep vein thrombosis (no further information regarding treatment) - in rsa group.
|
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
|