SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS TITANIUM SHELL 3-49 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER,
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Catalog Number 75003740 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Bone Fracture(s) (1870); Local Reaction (2035); Inadequate Osseointegration (2646)
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Event Date 03/02/2020 |
Event Type
Injury
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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 bicon-plus titanium shell 3-49 non-cem, a peri-prosthetic fracture of the sl-plus standard stem 7 non-cemented, wear of the bicon-plus pe insert antil 3/28 non-cem and an adverse soft tissue reaction to particulate debris.This event was addressed via revision surgery on (b)(6) 2020 to explant cup, liner, head and/or stem.Patient 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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Internal complaint reference: case (b)(4).
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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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