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(b)(4).Report source: (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: oxf anat brg lt md size 3 pma catalog #: 159547 lot #: 6414050, medical product: oxf uni cmntls tib sz f lm catalog #: 166580 lot #: 3808976.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred united kingdom.Products have been returned to biomet uk ltd for evaluation and forwarded to the product evaluation complaints engineer for investigation, conclusion of failure analysis is as follows: an oxford partial knee system was revised due to loosening of the femoral component after approximately 10 months.All components were returned for evaluation.Visual inspection of the metal components showed the presence of fragments of bone tissue attached to the porous coated surfaces, suggesting some degree of bone integration.Scratches, wear and indentations were observed on the articulating surfaces of the metal components.Scratches and pitting were found on the articulating surfaces of the polyethylene bearing.The provided radiographs showed that third body debris was present within the joint space.Two of the four provided radiographs showed that the femoral component had detached from the femur and had dislocated in the anterior joint space, thus confirming loosening of the component.The provided surgical notes from the revision procedure reported that femoral cysts were observed during surgery.The root cause of loosening of the femoral component could not be confirmed without further patient information being provided.However, the presence of third body debris within the joint space and sub-optimal bone stock quality may have been contributing factors to the early failure of the device.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.The manufacturing history records (mhrs) of the returned components have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.No corrective or preventive actions are deemed necessary at this time.The relevant instructions for use for the femoral component state that: warnings: do not directly impact on any surface coated with porous and / or hydroxyapatite coating.Any damage to the coating may lead to poor fixation, wear and subsequent loosening of implant component.Do not allow porous coated surfaces to come into contact with cloth or other fibre releasing materials.In the event of excessive bone removal or inaccuracies in bone cuts leading to loose fit of cementless implants into the prepared bone, the oxford cemented implants should be used.In this case the cemented oxford instrument kits must be used and trial reduction must be conducted to ensure the natural knee kinematics are maintained.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 knee and can result in device failure or dislocation.Precautions: extra caution must be taken during the handling of porous / hydroxyapatite coated implant components.Any damage to the coating may cause loose ti and hydroxyapatite particles to migrate into the joint space leading to excessive wear and subsequent loosening of implants.Postoperative care is important.Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure.The patient must be warned of the limitations of the reconstruction and the need for protection of the implants from full 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, unusual and / or awkward movements and / or activity, trauma, excessive weight, obesity have been implicated with premature failure of the implant by loosening, fracture, dislocation, subluxation and / or wear.Loosening of the components can result in increased production of wear particles, as well as accelerating damage to bone, making successful revision surgery more difficult.The patient is to be cautioned to govern activities accordingly, thus protecting the replaced joint from unreasonable stresses and must be informed of the importance of following the instructions of his treating physician with respect to follow-up care and treatment.Secure fixation of all cementless components at the time of surgery is critical to the success of the procedure.Each component must correctly pressfit into the host bone, which necessitates precise operative technique with the use of specified biomet joint replacement instruments.The use of instruments or implant components from other biomet systems and third party systems can result in inaccurate fit, sizing, excessive wear and device failure.Risk assessment and occurrence: the root cause of the loosening could not be confirmed with the information provided and from the assessment of the returned devices although it is possible that the presence of third parry debris in the joint space and poor bone stock contributed to the event.Since a specific hazard cannot be selected, risk assessment is based on severity associated with the harm of loss of fixation/non-integration, which is a harm that is listed as a potential outcome of a number of hazards.Since the outcome of this complaint is a revision surgery, the severity is considered in line with the rmf.Occurrence score could not be compared to an estimated occurrence of this event, since the root cause and specific hazard could not be determined.Sales data for item (b)(4) are attached over a period 3 years prior to the notification date of the complaint (2016 to 2020).Sales over this period are (b)(4).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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