SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP PE INSERT 49/28 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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Model Number 75017221 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994)
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Event Date 11/12/2018 |
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 right thr revision surgery, where a polarcup pe insert 49/28 non-cem, was implanted, the patient underwent a revision surgery on (b)(6) 2018 to explant liner and head, due to unexplained pain and adverse soft tissue reaction to particulate debris.Current health status of the patient 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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Section a2 and d10 were updated.Section h10: 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.Internal complaint reference number: (b)(4) section h6 (clinical code and medical device problem code) was corrected.
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