On november 10st, 2020 stryker trauma and extremities acquired tornier sas.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.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Incidence of hematoma alone, although relatively common, does not affect the overall outcome of reversed total shoulder arthroplasty.No specific risk factor could be associated with development of hematoma, proper placement of the implant is necessary to avoid fluid collection in empty areas or what are called dead spaces.The pulmonary embolism is a complication not specific to the device, but which could occur following a surgical act.At the last follow-up, no other complication was recorded: no prosthetic instability, infection or implant loosening was encountered, and no patients required further surgery.Based on the low available information, there is no evidence that this case is related to the device, root cause cannot be clearly determined.
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From literature "reverse shoulder arthroplasty for acute fractures in the elderly: is it worth reattaching the tuberosities?" boileau p et al., jses, 2019, 28:437-444.Two temporary early postoperative complications occurred, and both were treated medically: 1 patient had a hematoma along the upper limb, and another had a pulmonary embolism.
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