SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 71302804 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hip Fracture (2349)
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Event Date 05/24/2021 |
Event Type
Injury
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Event Description
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On the pmcf titled dca-1000 accord ss clinical dataset, it was reported that, after undergoing left hip hemiarthroplasty, one (1) patient experienced displaced femoral neck fracture.This adverse event was treated by performing an internal fixation surgery on (b)(6) 2021, in which an accord cable system was implanted.A post-operative follow-up determined a good alignment with no evidence of fracture or loosening.
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post-market clinical follow-up activity that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
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Manufacturer Narrative
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Given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, this complaint derived from a post-market clinical report, as part of a retrospective data collection.The provided clinical dataset was reviewed; however, as of the date of this medical investigation, patient-specific supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the information provided.No further clinical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed in warnings and precautions that congenital deformity, improper implant selection, improper broaching or reaming, osteoporosis, bone defects due to misdirected reaming, trauma, strenuous activity, improper implant alignment or placement, patient non compliance, etc.Can increase risk of femoral or pelvic fractures.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, excessive forces, abnormal loading of limb and/or patient bone quality.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Manufacturer Narrative
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Correction: (b)(4).Initial complaint was created against cocr 12/14 fem head 28 + 4; a case re-assessment determined that, since a femur fracture occurred, complaint must be against the femoral stem.
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