On november 10th, 2020 stryker trauma and extremities acquired tornier (b)(4).An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Glenoid loosening problem with a screw rupture at 6 years post-operative.Glenoid loosening can be related to several reasons: initial poor bone quality (osteoporosis) or insufficient quantity of bone stock glenoid fracture during the insertion of the baseplate (tapping step not realized for threaded post-baseplate for example).Inadequate choose of the glenoid implant components.Improper positioning of the glenoid implants components.Severe notching phenomenon leading to bone destruction.High wear rate of the polyethylene insert leading to bone resorption.Traumatic event.Reeducation procedure not respected or inadequate patient use in post-op (surgeon advices not respected).Atraumatic osteonecrosis detected into this particular case could have been considered as a contra-indication for a reverse arthroplasty (see instruction for use ifu utawi2017.1).However, not enough information is given into this complaint to determine if the glenoid side was affected or not.Based on the low data available, the root cause could not be clearly determined.
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