SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL NON-CEMENTED (TI-PLASMA OR TI/HA); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNKNOWN |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Failure of Implant (1924); Osteolysis (2377); Inadequate Osseointegration (2646)
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Event Date 03/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (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) 2006, the patient experienced lysis around the acetabular cup, loosening and malalignment of the acetabular cup.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.During this procedure, the acetabular cup was explanted.The patient's health status is unknown.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent either a revision or re-revision surgery where a polarcup shell was part of the hip construct.As such, no further information will be available.
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Manufacturer Narrative
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A total of 70 revision surgeries involving polarcup devices was reported by the uk national joint registry.104 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.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.Internal complaint reference number: (b)(4).
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Search Alerts/Recalls
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