After further review of additional information received the following sections a1, b4, b5, b6, b7, d4, g1, g3, g4, g5, g7, h1, h2, h3, h4 and h6 have been updated accordingly.Section h3: the complaint products were not returned for analysis.The device condition of wear was not confirmed.The frequency of occurrence ranking is very low; therefore, this does not appear to be a design issue.The company is not aware of receiving any other complaint reports involving another part from this manufacturing lot of 50 (replicator plate), 49 (torque screw square drive kit), 32 (humeral stem), 34 (glenoid) and 50 (humeral head) pieces that have been in the field since 2012, 2012, 2012, 2010 and 2012, respectively.Therefore, this issue does not appear to be manufacturing related.Aseptic glenoid loosening and prosthesis wear as a long-term complication is predictable in active patients.The prosthesis wear reported was likely the result of being implanted for 6 years and experiencing loads consistent with patient body weight during normal activities.However, this cannot be confirmed because the devices were not available for evaluation and adequate information was not provided.Section h6: in a review of the labeling, it is known that device specific risks consist of: fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.It is known to be contraindicated in the following situations: patients whose weight, age, or activity level might cause extreme loads and early failure of the system.There is no patient information provided; therefore, it is not possible to assess the patient risk/clinical factors.This device is used for treatment not diagnosis.In the investigation of this event, additional information has been requested.No new information has been provided.Section(s): no information a2, a4-6.
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