MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI FEMORAL MD; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted (awaiting revision date).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on an unknown date.Subsequently, the patient presented with pain and as a result an arthroscopy was carried out on (b)(6) 2020 and synovasure test was performed.The result is unknown but the implant effected is the oxford cemented femur.Awaiting date for revision surgery.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2019.The patient presented with pain and as a result an arthroscopy with aspiration to rule out infection and confirm implant loosening was carried out on (b)(6) 2020, and synovasure test was performed.The result is loose femoral component.Confirmed by arthroscopy.Samples taken, synovasure negative and no organism grown.Cement was found to have good bond to the implant and interdigitation into the bone.Subsequently, revision surgery was carried on (b)(6) 2020 due to loose femoral component.It was also noted by the surgeon that a lucent line was visible on x-ray.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.G3: report source, foreign - event occurred in united kingdom.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Medical product: 159575, catalog #: oxf anat brg rt md size 3 pma, lot #: 6029832.Additional information received: the femoral component (item # 154601, lot # j6269563, oxford uni femoral md) returned together with the bearing (item # 159575, lot # 6029832, oxf anat brg rt md size 3 pma).The bearing is considered as an associated device, as the incident is related only to the femoral component.Patient information is not allowed by country regulations.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2019.The patient presented with pain and as a result an arthroscopy with aspiration to rule out infection and confirm implant loosening was carried out on (b)(6) 2020, and synovasure test was performed.The result is loose femoral component.Confirmed by arthroscopy.Samples taken, synovasure negative and no organism grown.Cement was found to have good bond to the implant and interdigitation into the bone.Subsequently, revision surgery was carried on (b)(6) 2020 due to loose femoral component.It was also noted by the surgeon that a lucent line was visible on x-ray.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2019.The patient presented with pain and as a result an arthroscopy with aspiration to rule out infection and confirm implant loosening was carried out on (b)(6) 2020, and synovasure test was performed.The result is loose femoral component.Confirmed by arthroscopy.Samples taken, synovasure negative and no organism grown.Cement was found to have good bond to the implant and interdigitation into the bone.Subsequently, revision surgery was carried on (b)(6) 2020 due to loose femoral component.It was also noted by the surgeon that a lucent line was visible on x-ray.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Product has been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.An oxford partial knee femoral component and meniscal bearing were revised after approximately 1 year and 1 month due to loosening.The available relevant manufacturing history record indicate that the items were manufactured in accordance with the applicable specifications.Visual examination of the returned components suggested that suboptimal cementing technique, impingement and/or the presence of third body debris may have been contributing factors to the revision.However, this could not be confirmed with the available information.The relevance of patient-related factors could also not be assessed without patient information.The available mhr reviews indicate that the products were most likely conforming to design specification when they left zimmer biomet control.Radiographs: two mediolateral (ml) radiographs were provided with (b)(4).One radiograph was labelled 6 months post-op by the sales representative, and one was labelled immediately to revision surgery.Anteroposterior (ap) radiographs are required for the full assessment of the fit and positioning of components.These have been requested but were not received at the time of writing this assessment.On the provided ml radiographs, the positioning and sizing of the tibial tray appear to be in agreement with the recommendations of the oxford surgical technique.A small gap or radiolucent line is visible between the femur and the posterior portion of the femoral component at 6 months after surgery.This feature remains present on the pre-revision radiograph.There is also a radiolucent line visible posterior to the femoral peg of the component at this time point.This is in agreement with the complaint description, which states surgeon said there was a lucent line visible on x-ray.Patient information has not been provided due to country regulations.Surgical notes for the primary and revision surgery were also not provided, but the sales rep reported that no unexpected issues were encountered.Prior to the revision surgery, it was reported that loosening of the femoral component was confirmed with arthroscopy, whilst infection was ruled out using synovasure lateral flow test and microbiology cultures.Following the revision surgery, it was reported by the sales rep that the cement was found to have good bond to the implant and interdigitation into the bone.The revised component, as well as a polyethylene bearing, have been received but have not been examined at the time of writing this review.The instructions for use included with the oxford femoral component provided the following information: warnings: 7.Care is to be taken to ensure complete support of all parts of the device embedded in bone cement to reduce the risk of stress concentrations, which may lead to failure of the procedure.Complete preclosure cleaning and removal of bone cement debris, metallic debris, and other surgical debris at the implant site is critical to minimise wear of the implant articular surfaces.Implant fracture and loosening due to cement failure has been reported.Precautions: 5.Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone making successful revision surgery more difficult.The patient is to be made aware and warned in advance of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician including follow-up visits.Possible adverse effects: 10.Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.20.Persistent pain.Risk assessment: the event reports pain and loosening.Risk management report documents the estimated residual risk associated with the reported event.Failure analysis report concludes: an oxford partial knee femoral component and meniscal bearing were revised after approximately 1 year and 1 month due to loosening.Visual examination of the returned components suggested that suboptimal cementing technique, impingement and/or the presence of third body debris may have been contributing factors to the revision.However, this could not be confirmed with the available information.The relevance of patient-related factors could also not be assessed without patient information.The reported event states pain.Pain is documented as a potential harm as an outcome of a number of hazards assessed by the rmf.Pain is considered a severity of 3: moderate, which as per the severity table listed within the rmr is defined 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 reported event also states loosening.Loss of fixation is documented as a potential harm as an outcome of a number of hazards assessed by the rmf.Loss of fixation is considered a severity of 3: moderate, which as per the severity table listed within the rmr is defined 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 reported event is considered to be within the severity of the rmf.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 years prior to the notification date, being (b)(6) 2020.Sales (july 2017 to july 2020) = (b)(4) units (see sales report for list of item numbers).Complaints search was conducted for events occurring between july 2017 to july 2020 for item 154601.3 complaints were identified for this item number including (b)(4).Therefore, the calculated occurrence rate is (b)(4).Occurrence calculation = 3: occasional.Rmf estimates = 3: occasional.If further information regarding the root cause of the reported event is provided, risk should be re-assessed.Preventive & correction actions taken: no corrective or preventive actions are considered necessary at this time.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.

• Brand Name: OXFORD UNI FEMORAL MD
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10361032
• MDR Text Key: 201516026
• Report Number: 3002806535-2020-00357
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388073
• UDI-Public: 05019279388073
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154601
• Device Lot Number: J6269563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other