SMITH & NEPHEW, INC. IMAGE HA HIP SZ 9MM LEFT; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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Catalog Number 76098231 |
Device Problem
Fracture (1260)
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Patient Problems
Fall (1848); Failure of Implant (1924)
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Event Date 09/20/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that, after a tha system had been implanted on (b)(6) 2001, the image ha hip sz 9mm left cone fractured in a fall on a cruise ship on (b)(6) 2023.It is unknown whether the revision surgery has already occurred or not.Current health status is also unknown.
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Event Description
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It was reported that, after a tha system had been implanted on (b)(6) 2001, the image ha hip sz 9mm left cone fractured in a fall on a cruise ship on (b)(6) 2023.The revision surgery was performed on (b)(6) 2023 to replace the s+n stem and the merete bioball delta head with its adapter with an s+n sl mia stem and a ceramic head from an unspecified manufacturer.The patient underwent a subsequent revision surgery on (b)(6) 2023 to replace such a head after recurring dislocations.
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Manufacturer Narrative
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H10.Additional information in b5.
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Event Description
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It was reported that, after a tha system had been implanted on (b)(6) 2001, the image ha hip sz 9mm left cone fractured in a fall on a cruise ship on (b)(6) 2023.The revision surgery was performed on (b)(6) 2023 to replace the s+n stem and the merete bioball delta head with its adapter with an s+n sl mia stem and a ceramic head from smith+nephew.The patient underwent a subsequent revision surgery on (b)(6) 2023 to replace such a head after recurring dislocations.
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Manufacturer Narrative
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Additional information: d6b (explanted date), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated device was returned and evaluated.The visual inspection revealed the implant fractured into two pieces.The visual also reveals the ceramic head is still attached to the implant.The clinical/medical investigation concluded that, the provided photos of the explants and x-ray image dated (b)(6) 2023 validates the reported stem breakage.The acetabular cup remains in situ as well as the cemented non s+n insert.The fracture of the stem is likely related to the patient¿s fall as reported.Based on the information provided, there is no evidence of a malperformance of the implant.The impact to the patient is limited to the revision surgery and the associated recovery period.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 that fracture of the implant can occur as a result of trauma, strenuous activity, improper alignment, or duration of service.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.According with inspection procedure, the part configuration should be verified per print.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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.Corrected data: b5 (narrative), d9&h3 (sample returned for analysis), e4 (reporter did not submit a report to fda), h6 (health effect - clinical code).
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Manufacturer Narrative
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Updated results of investigation: the associated device was returned and evaluated.The visual inspection revealed that the implant fractured into two pieces.The visual also reveals the ceramic head is still attached to the implant.The clinical/medical investigation concluded that the provided photo of the explants and x-ray image dated (b)(6) 2023 validates the reported stem breakage.The acetabular cup remains in situ as well as the cemented non-smith and nephew insert.The fracture of the stem is likely related to the patient¿s fall as reported.Based on the information provided, there is no evidence of a malperformance of the implant.The impact to the patient is limited to the revision surgery and the associated recovery period.A laboratory analysis performed on the device revealed that the image ha hip stem revealed a degree of bone attachment in the proximal region.Scratches were observed on the polished section of the stem neck which could have been generated during implantation or by contact with the neck fragment following the fracture.The fracture surface of the neck shows a notable shear lip footprint where the fracture was completed due to overload.The possible location for the fracture initiation would be expected near or at the proximal lateral aspect of the neck based on anatomical loading.Based on visual observations, the stem fractured by initiation and subsequent fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-section could not bear the imposed patient loading after a fall, which led to an overload fracture.Fatigue cracking is often caused by the cyclic stresses exceeding the endurance limit of the stem¿s material for an extended period of time.No material or manufacturing deviations were observed during this investigation.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 that fracture of the implant can occur as a result of trauma, strenuous activity, improper alignment, or duration of service.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.According with the inspection procedure, the part configuration should be verified per print at this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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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