SMITH & NEPHEW ORTHOPAEDICS AG UNKN. BICON-PLUS SHELL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Catalog Number UNKN1100402 |
Device Problems
Loss of Osseointegration (2408); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2015 |
Event Type
Injury
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Event Description
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On the literature article named "ten to fifteen-year clinical and radiographic follow-up with a third-generation cementless stem in a young patient population", it was reported that, after a bicon-plus shell had been implanted on 1 patient, patient #15 of the study, a revision surgery was performed 12,5 years after the primary surgery due to wear and aseptic loosening.The bicon cup, bicon insert and femoral head were explanted.Patient outcome is unknown.
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Manufacturer Narrative
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H3, h6: the study of studers p.[1] reports 311 primary thas performed in 276 patients between 1996 and 2000 using a sl-plus stem.Eight cases required revision of a bicon component.It is reported, that in one case a revision surgery was performed 12,5 years after the primary surgery due to wear and aseptic loosening.The complaint device, used in treatment, was not returned for investigation, hence the product evaluation could not be conducted.A complaint history review was performed.The batch record review could not be performed as the batch number of the device is not known.Severity and the failure mode are covered through our risk management.The reported failure mode might occur in some cases, which is stated as a side effect in the ifu lit.No.12.23 ed.05/16.No patient information nor any other medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on the conducted investigation the failure mode could not be confirmed independently.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is neither possible to investigate whether the reported device met manufacturing specifications upon release for distribution nor to speculate about factors which could have contributed to the reported event.The root cause of the problem stays undetermined.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.This investigation is considered closed.[1]: studers p, belajevs d, jurkevics v, likums p.Ten to fifteen-year clinical and radiographic follow-up with a third-generation cementless stem in a young patient population.Int orthop.2016 mar;40(3):465-71.Pmid: 26224612.
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