Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign source: norway.Https://doi.Org/10.1186/s13018-022-02947-3.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
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Event Description
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It was reported in a journal article that was retrieved from the journal of orthopaedic surgery and research from a study from norway.The purpose of the study was to investigate whether the use of blunt pegs instead of pointed screws reduced the risk of penetration into the glenohumeral joint during fracture healing after operatively treated proximal humerus fractures.The study reviewed two groups, anatomical locking plate system-proximal humeral plating (zimmer biomet alps-php) and the proximal humeral internal locking system (syntheses solothurn, switzerland philos).It was reported that one patient underwent implantation of an alps-php following a proximal humeral fracture.Subsequently, the patient underwent removal of one locking peg due to loosening, without signs of non-union or infection.Attempts have been made and there is no further information at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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