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(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Device available for evaluation: the product has been requested to be returned to zimmer biomet for investigation.Concomitant medical devices: medical product: g7 hi-wall e1 liner 32mm d, catalog #: 010000926, lot #: 3602595; medical product: g7 bonemaster ltd acet shl 50d, catalog #: 010000702, lot #: 6007375; medical product: unknown stem, catalog #: unknown, lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.
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(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.A fractured high wall e1 polyethylene acetabular liner, g7 bonemaster acetabular shell and biolox delta ceramic femoral head were received for analysis.Visual examination of the ceramic head and g7 shell confirms articulation between the two, which is in agreement with the liner fracture and dissociation reported in the complaint description.Three images with four radiographs were provided with (b)(4): one full pelvis anteroposterior radiograph and one lateral radiograph, taken on (b)(6) 2021, 7 days before revision; one full pelvis anteroposterior radiograph and one lateral radiograph, taken after revision on an unknown date.The radiographs taken after revision are not relevant for this assessment.Immediate post-primary surgery radiographs are required to assess the initial fit, size and positioning of components.These have been requested, but were not available.The quality of the provided pre-revision full pelvis radiograph does not allow for the inclination angle of the acetabular shell to be accurately measured.However, the femoral head appears off-centred with respect to the acetabular shell, thus confirming the reported disassociation of the liner from the shell.The distal portion of the microplasty stem appears to be loading the lateral wall of the intramedullary canal of the femur.The revision surgical notes provided with (b)(4) inform that the microplasty stem was found well fixed, with the taper in good condition, and was therefore left in vivo.The liner had dislocated, as expected from the radiographs, and the acetabular shell was found well fixed, but damaged.The 50d g7 acetabular shell was revised to a size 54 trilogy shell with four screws, whilst the e1 liner was replaced with a ceramic liner, and the -3mm ceramic head was revised to a +6mm ceramic head of the same size, thus suggesting that some degree of soft tissue laxity may have been present.The surgeon that performed the revision surgery reported: from the history i got that there was discomfort on and off worse in the preceding 2 weeks prior to the referral made to me and i got her operated within a week from consultation.In addition, he reported that there was black metal staining inside the capsule with little normal colour joint fluid, macroscopically not infected.The liner had broken a couple of segments from the inferior aspect of the high wall and i suspect that the reason for it was repeated impingement as in my experience a liner incorrectly seated tends to slip out early within days.It was reported that the patient is female and was 66 at the time of revision.Her height, weight or bmi are unknown due to country regulations, but the revision surgeon described her as reasonably fit, although post op she had minor aki.Note that the complaint description and the event timeline provided on etq report that trauma after surgery, rta occurred, however the surgeon that carried out the revision surgery informed that the patient denied any trauma or fall contributing to this event.The manufacturing history records (mhrs) of the revised components have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.The instructions for use provided with the ceramic head warn that: improper selection, placement, positioning, alignment and/or 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.Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure.Accepted practices in postoperative care are important.Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure.The patient is to be advised of the limitation of the reconstruction and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred.Excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of certain implants by loosening, fracture, dislocation, subluxation and/or wear.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.It is not possible to confirm impingement as the root cause of the implant failure in this instance, as suggested by the surgeon, without examination of the revised components.These have been returned to zimmer biomet, but have not been received in the research department.Joint laxity may also have been a contributing factor for the early failure; other contributing factors cannot be discussed without further radiographs and patient information.The root cause of the liner fracture and dissociation could not be determined in this instance.However, as pointed by the surgeon who performed the revision surgery, suboptimal liner placement and/or impingement may have been contributing factors.Capa: no corrective or preventive action required at this time.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.
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