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(b)(4).Initial report.Customer has indicated that the product has been discarded.Associated products: medical product: e-poly 36mm +3 maxrom lnr sz23, catalog #: ep-108223, lot #: 338390.Medical product: rnglc+ ltd hole fin shl sz52, catalog #: 16-104152, lot #: 490600.Medical product: ti low profile screw 6.5x25mm, catalog #: 103532, lot #: 120850.Medical product: tprlc 133 fp type1 pps so 8.0, catalog #: 51-100080, lot #: 3809695.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00219 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.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records, complaint history and x-ray review.In addition, we have not been provided with any supporting documentation which could provide additional information.Four full-pelvis anteroposterior (ap) x-rays were provided for analysis with (b)(4): two post-primary x-rays, taken on (b)(6) 2016, respectively; one pre-revision x-rays, taken on (b)(6) 2021; and one post-revision x-ray, taken on (b)(6) 2021.The zimmer biomet product experience report (zper) mentions that the primary surgery, where the patient received a ringloc finned acetabular shell with a titanium screw, a vitamin-e polyethylene liner, a biolox delta option femoral head, a biolox option taper sleeve and a taperloc porous plasma spray (pps) femoral stem, was performed on (b)(6) 2016.During revision surgery on (b)(6) 2021, where the head, taper sleeve and liner were removed and replaced, it was discovered liner was broken.The patient, female, was 53 years old at the time of surgery.The zper further states that it is unknown whether there were any contributing conditions related to the event, and that the surgical technique for the product was utilised.In the post-primary x-ray dated (b)(6) 2016, the inclination angle of the acetabular shell was measured to be 60.7°, which is higher than the recommended surgical inclination angle in the ringloc surgical technique of 40 to 45 degrees.Although the quality of the pre-revision and the post-revision x-rays is suboptimal because their photographs were taken at an angle, the inclination angle of the acetabular shell appeared steep and was measured to be 61.6° and 62.1°, respectively, which confirms the high inclination angle measured in the post-primary x-ray.In the pre-revision x-ray dated (b)(6) 2021, the femoral head has dislocated laterally from the acetabulum, as reported in the complaint description.As stated in email communications attached to (b)(4), the patient is 1.57 m tall and weighs 56.9 kg, thus having a bmi of 23.1 (normal weight).That email further mentions that details about the patient¿s activity level and surgery records were not available.Linked complaint (b)(4) covered the vitamin-e polyethylene liner.The radiograph dated (b)(6) 2021 was assessed in a maven md reviewer case report (medical metrics inc.), dated (b)(6) 2021 and attached to (b)(4), which states that no abnormal radiolucency is noted and there is no evidence of implant loosening, and that the left hip acetabular implant abduction angle measures approximately 62 degrees, which is elevated above the range of normal.The same report also states that bone quality appears osteopenic.The instructions for use provided with the biolox delta femoral head mention the following: warnings: improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.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.The manufacturing history records (mhrs) for the biolox delta option femoral head, biolox option taper sleeve, ringloc finned acetabular shell, titanium low profile screw and taperloc pps femoral stem have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.The mhr for the vitamin-e polyethylene liner, provided with (b)(4), has been checked and verifies that the component was manufactured and sterilised in accordance with the applicable specifications.It is not possible to confirm the cause of dislocation without the provision of surgical notes for both surgeries and analysis of the retrieved implants.However, improper implant positioning, namely a higher than recommended inclination angle of the acetabular shell, may have been a contributing factor.A review of the complaint database over the last 3 years has found 1 complaint reported with the item 650-1064 and item 650-1057 (initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00219-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product discarded.
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