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Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)
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Event Date 03/29/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Cat# 650-1058 lot# 2746080 cer bioloxd option hd 40mm, cat# 650-1067 lot# 2609978 cer option type 1 tpr sleve +3, cat# 11-301331 lot# 983840 arcos con sz a hi 70mm, cat# 5200-54 lot# 0112i innomed starter blade size 54, cat# 5201-54 lot# 0112i innomed finish blade size 54, cat# 103533 lot# 200450 ti low profile screw 6.5x30mm, cat# 103536 lot# 056750 ti low profile screw 6.5x45mm.Foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported the patient had a left hip revision in 2012 due to a periprosthetic fracture from a fall.Subsequently, they began to experience pain and a bone scan displayed loosening of the stem.Approximately 11 years after initial surgery, the patient underwent a revision for aseptic loosening.The stem, head, liner, cup, and proximal plating system were all revised without complication.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: record review - revision of left total hip arthroplasty for aseptic loosening.Bone scan shows loosening of the stem.X-ray review - overall osteopenia.Significant amount of heterotopic ossification along the left hip joint superiorly with possible bony bridging.Lateral plate device appears to be far superior to the expected location of the greater trochanter suggesting possible loosening.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 further information at the time of this report.
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Search Alerts/Recalls
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