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(b)(4).Initial report.Foreign report source: (b)(6).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.Concomitant medical products: medical product: g7 bonemaster ltd acet shl 52e, catalog #: 010000703, lot #: 6684512.Medical product: g7 neutral e1 liner 36mm e, catalog #: 010000857, lot #: 6643700.Medical product: tprlc 133 mp type1 bm ho 16.0, catalog #: 51-117160, lot #: 6514003.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states revision due to implant fracture - device fracture or damage to acetabular components.These lines have a severity score of 3 which is defined in the rmr as: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (surgical intervention) is considered to be within the severity of the rmf.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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(b)(4).This final / follow-up report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Radiographs received: four radiographs were provided with cmp-0634456 for review, although two radiographs appear to be identical, therefore only three radiographs are relevant for this assessment: one anteroposterior (ap) radiograph of the left hip taken 6 weeks after the primary surgery, and one full pelvis ap radiograph and one lateral radiograph both taken before revision.Further radiographs were requested but were not available.It is stated in the electronic zimmer biomet product experience report (zper) that 6 weeks post operative x-rays also attached as there is a definite implant issue at this stage that was not reported on by radiology.Patient reported no issue at time of 6 week follow up.The provided radiograph labelled 6 weeks post-op shows the presence of a large fragment lateral to the stem neck, thus confirming that the head fracture had already occurred at this time-point.The two radiographs taken before revision show the head clearly fractured in large fragments visible around the stem neck, as well as numerous smaller fragments scattered within the joint space.The inclination angle of the acetabular cup was measured to be 44.4 degrees.The g7 surgical technique states that the preferred acetabular orientation is 40 degrees inclination and 20 degrees of anteversion, but final acetabular position depends on patient anatomy and may vary slightly with approach.The instructions for use provided with the ceramic head inform that: warnings: 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 activity levels and loads of normal healthy bone and joint tissue.Excessive activity, trauma, and excessive weight have been implicated with premature failure of the implant by loosening, fracture, and/or wear.Possible adverse effects: loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, non-union, bone resorption, and excessive activity.It is unknown whether any event or trauma occurred that may have caused the ceramic femoral head to fracture.The patient is female, 68 years-old, weighs 70 kg and is 1.69 m, therefore her bmi is healthy.Her activity level is reported to be moderate.Surgical notes have been requested but have not been received at the time of writing this assessment.It is reported in an email communication available on etq that the surgeon has taken the implants to test independently.It is unknown what the outcome of this investigation is.The manufacturing history records (mhrs) of the biolox delta ceramic head have been checked and verify that the part was manufactured and sterilised in accordance with the applicable specifications.Based on the information provided, it appears that the head fracture occurred within the first 6 weeks after surgery.However, the implant was left in vivo for another 2 months before it was revised with the polyethylene liner and the femoral stem.It is not possible to determine the cause of the implant failure with the available information and without provision of the revised components.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information, furthermore, the supplied photograph does not yield any information that could identify the cause.Risk assessment: the event reports revision due to implant fracture.Risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states revision due to implant fracture.This incident has a severity score of 3 which is defined in the rmr as: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (surgical intervention) is considered to be within the severity of the rmf.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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