SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 5 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER
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Model Number 75002703 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 05/12/2015 |
Event Type
Injury
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Event Description
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It was reported that, after a right tha had been performed on (b)(6) 2015, the patient suffered a peri-prosthetic fracture on the sl-plus standard stem 5 non-cemented.This event was addressed via revision surgery on (b)(6) 2015 to explant head and stem.Patient health status is not known.This information was provided by the national joint registry of the (b)(6), following a review of the data conducted in september 2021.Inspection of the data shows that the calculated ptir (revision rate per one hundred patient years of implantation) of bicon-plus is above the average 071 (0.57-0.88) for their group ptir¿s 0.38.Further information will not become available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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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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