Catalog Number 01.18.145 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Tissue Damage (2104)
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Event Date 12/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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On 03 dec 2015 we received the confirmation that the revision was successfully performed on 02 dec 2015 and that the explants will not be available.Batch review performed on 21 december 2015: lot 104362: (b)(4) items manufactured and released on 10 february 2011.Expiration date: 2016-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
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Event Description
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Due to a chronic and serious episode of osteoporosis, the stem presented a ditch and it was decided to remove the stem.Revision planned for (b)(6) 2015.
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Manufacturer Narrative
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X-rays received on 30 december 2015.On 01 january 2016, the medical affairs performed a clinical evaluation and commented as follows: aseptic loosening at 3 years in a patient with osteoporotic bone.The stem caused a very evident cortical thickening in gruen zones 3 and 5, but got loose in zones 1 and 7.Replacement with a cemented longer stem.Mobilization of a cementless stem is a known possible complication of tha; osteoporosis is a relative contraindication, meaning that the probability of mobilization in osteoporotic patients is statistically higher.Root cause for revision is aseptic loosening; cause for the latter is unknown, osteoporosis constitutes an objective difficult condition.
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Manufacturer Narrative
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On 29 january 2016 it was prepared a final report with the information already submitted in the previous reports.On the same date, the report was sent to the initial reporter and the case was closed.
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Search Alerts/Recalls
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