SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI COATED 53 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 75008733 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 07/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
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Event Description
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It was reported that after a left thr performed on (b)(6) 2007, the patient presented loosening of the polarcup shell ti coated 53 non-cem.This was addressed via revision surgery on (b)(6) 2016 and all devices were explanted.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.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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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 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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Manufacturer Narrative
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Additional information added: a1.Corrected data: d4 (lot number updated to unknown).
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Search Alerts/Recalls
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