BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM; PROSTHESIS, SHOULDER
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Model Number N/A |
Device Problems
Device Damaged by Another Device (2915); Scratched Material (3020); Noise, Audible (3273)
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Patient Problems
Pain (1994); Reaction (2414)
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Event Date 01/03/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Event Description
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A patient reported a right shoulder revision approximately 6 years post-implantation due to pain and a popping sound in the joint.Attempts have been made to obtain additional information; however, no further information is available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information and corrected information.Concomitant products: comprehensive screw: catalog#:180509, lot#: 852650.Comprehensive reverse shoulder glenoid baseplate: catalog#:115330, lot#:524560.Comprehensive reverse central screw: catalog#:115383, lot#: 256750.Comprehensive non locking screw: catalog#:180509, lot#: 852620.Comprehensive locking screw: catalog#:180504, lot#:029360.Comprehensive locking screw: catalog#:180505, lot#: 852240.Comprehensive reverse shoulder glenosphere: catalog#:115310, lot#:258260.Versa dial taper: catalog#: 118001, lot#:927850.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-01423, 0001825034-2017-02483, 0001825034-2017-02487, 0001825034-2017-02489.
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Event Description
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It is reported that the patient underwent right total shoulder arthroplasty revision approximately six (6) years post-operatively due to pain, implant fracture, and popping noises in the shoulder.Revision operative notes further noted thick fibrotic capsular tissue, metal-tinged fluid, small presence of metallosis, a fractured humeral tray implant with the post remaining in the humeral stem, and polyethylene wear.The stem, tray, and bearing were removed and replaced.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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(b)(4).The reported event is confirmed via photographs, x-rays, and operative notes received.X-ray review showed that the prosthesis was displaced and broken.Photos of the tray, stem, and bearing identified that the tray was scratched, nicked, and the taper was missing.The stem was scratched, nicked, pitted and the taper was fractured off from the tray and remains in the stem.The bearing was also worn, dented and had faded markings.Photos of devices; tray stem and bearing were received for evaluation.The root cause of the tray fracture is related to a previously addressed design deficiency related to the humeral tray component.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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