SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS TITANIUM SHELL 6-59 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER,
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Catalog Number 75003743 |
Device Problem
Failure to Align (2522)
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Patient Problems
Failure of Implant (1924); Inadequate Osseointegration (2646)
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Event Date 02/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Event Description
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It was reported that, after a left tha had been performed on (b)(6) 2005, the patient experienced loosening of the femoral stem and a malalignment of the acetabular cup.A revision surgery was performed on (b)(6) 2018 to treat this adverse event.During this procedure, all components were explanted.The patient's health status is not known.This information was provided by the (b)(6), following a review of the data conducted in september 2021.
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Manufacturer Narrative
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D4, h3, h6: a total of 84 revision surgeries involving bicon-plus devices was reported by the uk national joint registry.140 complaints were opened accordingly.A review of the device history record (dhr), of the complaint history (chr), of the instruction for use (ifu), of the risk management file (rmr) and of past escalation (per) was performed.No relevant supporting clinical information was provided.Based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Based on the chr and dhr evaluation performed there is no indication that any failure to meet specification contributed to the reported events.The reported failure modes are outlined in the device instruction for use lit no 12.23 03/21.The occurrence and severity of the reported issues are in line with the risk plans.The root cause of the reported events was attributed to known inherent risks of the devices.No corrective actions have been initiated.
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Search Alerts/Recalls
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