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(b)(4).Initial report.Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products: medical product: arcos sts dist stem 21x250mm, catalog #: 11-301021, lot #: 753680; medical product: arcos con sz e std 80mm, catalog #: 11-301345, lot #: 175530; medical product: depuy liner, catalog #: 87-3435, lot #: 793087 ; medical product: unknown cup, catalog #: unknown, lot #: unknown, multiple mdr reports were filed for this event, please see associated reports (add this for a multiple item complaint): 3002806535-2021-00268.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 and complaint history and x-ray review.In addition, we have not been provided with any supporting documentation which could provide additional information.Two hemi-pelvis anteroposterior (ap) radiographs have been provided with (b)(4): one pre-third-revision (taken on (b)(6) 2019) and one post-third-revision (taken on (b)(6) 2019).As mentioned in the medical record review form provided with (b)(4), the biolox option femoral head and biolox option taper adaptor associated with (b)(4) were implanted in the patient during the second revision surgery on (b)(6) 2016 and were retained during the third revision surgery on (b)(6) 2019.Other components that were retained during the third revision surgery were depuy s-rom poly-dial liner, s-rom screw, and acetabular component.Components that were implanted during the third revision surgery were biomet arcos bowed tapered splinted distal stem (21mm x 250mm) and cone proximal body (size e, standard offset, 80mm).Both pre- and post-third-revision radiographs show the femoral head within the acetabular shell and complex reconstruction of the acetabular region of the pelvis with multiple screws.Moreover, cerclage wires were used to stabilize the femoral components.The pre-third-revision radiograph shows that the oss femoral proximal body is clearly fractured and rotated.Some debris appears to be present on the post-third-revision radiograph, next to one screw in the superomedial region of the acetabulum, which is likely a fragment of a broken screw retained since the first revision surgery, as recorded in the provided operative notes dated (b)(6) 2013: the 1 locking screw on the rim was in fact broken around this polyethylene and was only able to be removed partially.Other debris may be present within the joint space, which may be fragments of bone or bone cement, or osteophytes.The patient (female) was 46 years old at the time of the third revision surgery.Other patient details such as height, weight, bmi, whether the patient was/is a smoker, or any contributing conditions to the reported event have not been provided.The patient underwent primary hip joint arthroplasty on an unknown date for an unknown reason.The first revision was carried out due to aseptic loosening of the femoral stem.Surgical notes recorded during this first revision, on (b)(6) 2013, report that the proximal femur itself had extensive ostoelysis and the lateral cortex in 1 portion was completely absent.Furthermore, the posterior aspect of this proximal femur was fractured.It was thin.In my opinion, avascular and incapable of supporting any revision component here, which is indicative of very poor bone quality in the region.In addition, the same notes also describe that there was not, in my opinion, and [sic] abductor sleeve present.There was a deep tissue layer that was mobile and not attached to the trochanter.I think this whole layer was fibrotic in this region and i do not believe that this was actually a muscular layer.We did preserve it and reconstructed it; however, i am uncertain that this is a functional layer of musculature.The joint was exposed and extensive scar was removed, which suggests that very poor soft tissue functionality may have also been present.The manufacturing history records (mhrs) of the biolox delta option ceramic head and biolox option taper adaptor associated with (b)(4) have been checked and verify that these components were manufactured and sterilized in accordance with the applicable specifications.Mhrs for the other zimmer biomet components relevant to the third revision surgery have been checked in the linked complaint (b)(4), where it is stated that a review of the device history records identified no deviations or anomalies during manufacturing.The instructions for use provided with the biolox delta option ceramic head and biolox option taper adaptor [1] provide the following relevant information: contraindications; relative contraindications include: 2.Osteoporosis.6.Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.7.Vascular insufficiency, muscular atrophy, or neuromuscular disease.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.1.Use biomet biolox delta option ceramic modular head with biomet metallic femoral components.Do not use biomet biolox delta option ceramic modular heads with femoral stems or acetabular components offered by other manufacturers.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.Possible adverse effects: 7.Undesirable shortening of limb.14.Intraoperative and postoperative bone fracture and/or postoperative pain.Based on the available information, it appears that the poor bone quality and poor soft tissue functionality encountered during the first revision on (b)(6) 2013 likely caused the need for the additional revision surgeries and therefore may have eventually contributed to the reported pain, lost mobility and leg length discrepancy by the patient.In addition, component compatibility (namely the femoral head and the acetabular component in this instance) cannot be ensured with the use of competitor products.Other contributing factors cannot be discussed without provision of information on the primary surgery, additional radiographs, additional patient information (bmi and pre-existing or contributing medical conditions or trauma) and without examination of components that were revised during the three revision surgeries.A review of the complaint database over the last 3 years has found 8 complaints reported with the item 650-1055 and 3 complaints reported with the item 650-1066 (including initiating complaint).Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00268-1.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 : remains implanted.
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