SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 4 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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Model Number 75002701 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994)
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Event Date 07/14/2021 |
Event Type
Injury
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Event Description
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It was reported that, after thr surgery had been performed on (b)(6) 2021, the patient experienced pain and fracture.This adverse event was treated with a revision surgery on (b)(6) 2021.Current health status of patient is unknown.
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Manufacturer Narrative
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H3, h6: it was reported that, after thr surgery had been performed on (b)(6) 2021, the patient experienced pain and fracture.This adverse event was treated with a revision surgery on (b)(6) 2021.The sl-plus standard stem 4 non-cemented (75002701) intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.Based on the limited information provided, a thorough medical assessment could not be performed.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.The ifu (lit.No.12.23 ed 05/16) lists the reported issue as a known possible side effect resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the performed investigation, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.A root cause cannot be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.
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