| Model Number N/A |
| Device Problems
Break (1069); Fracture (1260)
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| Patient Problems
Pain (1994); Hip Fracture (2349)
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| Event Date 08/15/2019 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Remains implanted.Report source: (b)(6).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported by the hospital that a patient was cycling and heard noise from his hip area.Subsequently, the patient went to the doctor for an x-ray which displayed that the ceramic head was broke.
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Event Description
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It was reported by the hospital that a patient was cycling and heard noise from his hip area.The patient went to the doctor for an x-ray which displayed that the ceramic head was broke.Subsequently, a revision surgery was performed due to the implant fracture.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Radiological images: three anteroposterior radiographs were provided with (b)(4) for review.One radiograph was taken on 6-aug-2018, 3 days after the primary surgery.The other two radiographs were taken on 19-aug-2019, 4 days after the fracture was reported to have occurred.The post-primary radiograph does not show the patient¿s full pelvis and therefore does not have the necessary bony landmarks to determine the inclination angle of the acetabular component.Both post-failure radiographs show that the ceramic head had fractured, as large fragments are visible near the displaced neck of the femoral stem.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the ceramic head fracture could not be determined in this instance without the provision of further radiographic, surgical and patient information, as well as the revised component.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported by the hospital that a patient was cycling and heard noise from his hip area.The patient went to the doctor for an x-ray which displayed that the ceramic head was broke.Subsequently, a revision surgery was performed due to the implant fracture.
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Event Description
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It was reported by the hospital that a patient was cycling and heard noise from his hip area.The patient went to the doctor for an x-ray which displayed that the ceramic head was broken.Subsequently, the patient was revised due to the implant fracture.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in germany.D11: device name: g7 neutral e1 liner 36mm f, model#: 010000858, lot#: 6323934.Products have been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.Product evaluation review: a fractured biolox forte ceramic head and e1 acetabular head were revised about 1 year after the initial procedure due to the fracture of the femoral head following the patient fall.The femoral head fragments and the e1 acetabular liner were received in the research department for evaluation.Metal transfer marks are observed on femoral head fragments, which may have occurred after fracture due to the interaction of the stem with fragments or due to interaction of instrument(s) used for removal of the fragments during the revision surgery.Fine horizontal marks are observed in the female taper region that follow the 12/14 taper groove pattern (figure 1).These are also mentioned in the revision surgery report as the taper shows distinct wear along approx.One third of its length, while the profile of the other two thirds is still good.These marks were likely to be present before the fracture of the liner and may have originated from taper engagement or imprinting of residue potentially present prior to the assembly of the taper.The e1 acetabular liner shows major damage with fracture and bending of a large portion of the liner.Deep gouging and extensive metal transfer is also observed in a region of the articulating surface.This damage agrees with the movement of the taper inside the acetabular shell.Corrective action, preventive action, and/or field action: no corrective or preventive actions are considered necessary at this time.Warnings and precautions: patients should be warned of the impact of excessive loading that can result if the patient is involved in an occupation that includes substantial walking, running, lifting, or excessive muscle loading due to weight that place extreme demands on the hip and can result in device failure or dislocation.Patient warnings: the patient is to be cautioned to govern activities, protecting the joint replacement from unreasonable stress conditions.Excessive activity, failure to control body weight and trauma affecting the joint replacement have been associated with premature failure of the reconstruction by loosening, fracture and/or wear of the implants¿.The patient must be warned that the device does not replace normal healthy bone and that the implant can break or be damaged as a result of excessive load bearing or trauma.Risk assessment: the reported event states revision due to implant fracture and is reported to have occurred after the patient fell.Line 3.1.2.7 of risk file ukf0591-bhp003 rev 03 is applicable; hazard: user error: excessive patient activity or post-operative trauma overloads the head.Hazardous situation: fracture or deformation of the head.Harm: non-functioning joint (as per description in cf03000 rev 5).Severity: moderate, 3: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary or medically reversible injury.Occurrence: remote, 2: (b)(4).Since the complaint reports revision surgery was undertaken, the outcome of this event in terms of the expected severity is as per the rmf and considered to be the severity of 3, moderate.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 calendar years prior to the event date, being (b)(6) 2019 (as per requirements of mir reporting).Sales (aug 2016 ¿ aug 2019 inclusive) = (b)(4) units.Complaints search was conducted for events occurring between jan 2016 ¿ to date for item 650-0664.There are no further complaints identified for this item number other than (b)(4).Therefore, the calculated occurrence rate is (b)(4).This is above the estimated acceptable occurrence rate as per the rmf ((b)(4) is considered an occurrence score of 3 occasional: (b)(4).Since the occurrence calculation is based on only 1 complaint, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a calculation based on one instance of a complaint.The failure mode will be monitored through zimmer biomet internal complaint and post market surveillance activities with further review of risk conducted through these processes.Conclusion: the biolox forte femoral head and an e1 acetabular liner were revised after about 1 year of implantation, following the fracture of the femoral head due to a fall.Both components were provided for evaluation.The relevant manufacturing history records indicate that the parts were manufactured and sterilised in accordance with the applicable specifications.Fragmentation of the femoral head, coupled with fracture and bending of a large portion of the e1 liner suggest the presence of abnormally high stresses during or after the fall.Metal transfer is also observed on femoral head fragments and at the site of the impact on the e1 liner.The mhr review indicates that the product was most likely conforming to design specification when it left zimmer biomet control, and the likely failure mode is femoral head fragmentation coupled with fracture and bending of the e1 liner due to abnormally high stresses.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.G3: report source, foreign - event occurred in germany.D10: the product has been returned to zimmer biomet for investigation.No preventive or corrective actions are deemed necessary at this time.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database has found no similar complaints reported with the item 650-0664.The post-primary radiograph does not show the patient¿s full pelvis and therefore does not have the necessary bony landmarks to determine the inclination angle of the acetabular component.Both post-failure radiographs show that the ceramic head had fractured, as large fragments are visible near the displaced neck of the femoral stem.The complaint description reports that the patient was cycling when the ceramic head likely fractured.The instructions for use provided with the head inform that [1]: ¿warnings and precautions: 8.Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients.While these devices are generally successful in attaining these goals, they cannot be expected to withstand the same activity levels and loads of normal healthy bone and joint tissue.23.Patients should be warned of the impact of excessive loading that can result if the patient is involved in an occupation that includes substantial walking, running, lifting, or excessive muscle loading due to weight that place extreme demands on the hip and can result in device failure or dislocation.Patient warnings: postoperative care is important.The patient must be warned of the limitations of the reconstruction and the need for protection of the implants from full weight bearing or load bearing until adequate fixation and healing has occurred.The patient is to be cautioned to govern activities, protecting the joint replacement from unreasonable stress conditions.Excessive activity, failure to control body weight and trauma affecting the joint replacement have been associated with premature failure of the reconstruction by loosening, fracture and/or wear of the implants.[¿] the patient is to be advised of the importance of postoperative follow-up examination and that excessive activity or trauma can lead to failure.The patient is to be warned in advance of the surgical risks and made aware of possible adverse effects.The patient must be warned that the device does not replace normal healthy bone, and that the implant can break or be damaged as a result of excessive load bearing or trauma.The patient must be warned to inform any other medical practitioner who may treat him in the future of the presence of the implant.The investigation is in process.Once the investigation has been completed, a final mdr will be submitted.
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Event Description
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It was reported by the hospital that a patient was cycling and heard noise from his hip area.The patient went to the doctor for an x-ray which displayed that the ceramic head was broke.Subsequently, a revision surgery was performed due to the implant fracture.
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Search Alerts/Recalls
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