BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD 42X18X46MM; PROSTHESIS, SHOULDER
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Model Number N/A |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Necrosis (1971); Pain (1994); Tissue Damage (2104); Post Operative Wound Infection (2446)
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Event Date 06/21/2015 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: the patient is to be made aware in advance of surgery and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician, including follow-up visits.This report is number 1 of 4 mdrs filed for the same event (reference 1825034-2017-01258 / 01261).
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Event Description
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It was reported that patient is experiencing possible late subscapularis failure 18 months post-implantation of right shoulder arthroplasty.No revision procedure has been reported to date.
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Manufacturer Narrative
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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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Event Description
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It was reported that a patient underwent a right total shoulder arthroplasty.Subsequently, the patient experienced unknown wound problems (dehiscence, necrosis, drainage, or superficial infection) thirty-eight days post-operatively.This was reported to be not device related, however related to the procedure, and reportedly resolved.At three month post-operative follow-up, instability was observed, however the patient was reportedly satisfied and had no issues.At the one year post-operative follow-up, instability was again observed and moderate pain was noted, however the patient still reported that they were satisfied and had no issues related to the shoulder.Lastly, possible late subscapularis failure was reported at eighteen months post-implantation.Outcome of treatment is pending.No revision procedure has been reported to date.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Root cause remains undetermined.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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Event Description
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It was reported that a patient underwent a right total shoulder arthroplasty.At three month post-operative follow-up, instability was observed, however the patient was reportedly satisfied and had no issues.At the one year post-operative follow-up, instability was again observed and moderate pain was noted, however the patient still reported that they were satisfied and had no issues related to the shoulder.Lastly, possible late subscalpularis failure was reported at eighteen months post-implantation.Outcome of treatment is pending.No revision procedure has been reported to date.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Concomitant medical product: comprehensive shoulder taper adaptor, catalog#: 118001, lot#: 465310; hybrid glenoid base, catalog#: 113952, lot#: 856280; pt hybrid glenoid post, catalog#: pt-113950, lot#: 019700.Event was confirmed by review of provided x-rays.Anterior subluxation of the humerus confirms the reported event of subscapularis failure.Radiolucency indicates possible glenoid loosening.An ossification projects over the axillary pouch on the ap view, possible lesser tuberosity avulsion bone fracture fragment.Review of the complaint history determined that no further action(s) is/are required.Root cause remains undetermined.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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