MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA LM/RL PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has been returned to zimmer biomet for investigation.Medical product: oxf anat brg lt md size 5 pma, catalog #: 159549, lot #: 257880; medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 214440.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00174, 3002806535-2020-00176.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 left knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D11: medical product: oxf anat brg lt md size 5 pma, catalog #: 159549, lot #: 257880.Medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 214440.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00174-1, 3002806535-2020-00176-1.As the product evaluation was not performed due to circumstances surrounding the covid-19 pandemic, complaint investigation is limited to the information provided; a review of device history records and complaint history.We have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 4 similar complaints for this item code 159549, 1 similar complaint for this item code 154718 and 34 similar complaints found for the item 161469.Trends could not be identified from the complaint history review because the reason for the revision is unknown.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to unknown reason.Risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison.At this time, no risk assessment can be conducted since the harm or reason for revision has not been be reported.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.Once we are in a position to review the product, we will immediately re-open the complaint and add the additional information which we may obtain from any visual, dimensional and analysis of the fracture.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00174-2, 3002806535-2020-00176-2.Product investigation completed: products have been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.-a left oxford partial knee system was revised after approximately 2 years and 6 months of implantation due to unknown reason.-the available relevant manufacturing history records indicate that the item was manufactured and sterilised in accordance with the applicable specifications.-implant examination suggests that the bearing may have articulated against third body debris such as osteophytes and/or bone cement fragments, and that alignment of the components may have been sub-optimal.However, this cannot be confirmed without additional information being provided such as surgical notes, patient and activity details, as well as post-primary and pre-revision radiographs.-the available mhr reviews indicates that the product was most likely conforming to design specification when it left zimmer biomet control, however it is not possible to confirm the root cause of the revision with the information available.Summary of medical records and/or x-ray records review: no radiographs have been provided for analysis with (b)(4), therefore an assessment of the component sizing, positioning and alignment could not be performed (see zper form section f within complaint).The instructions for use provided with the tibial tray and bearing and femoral component provides the following guidance: 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.-care is to be taken to ensure complete support of all parts of the device embedded in bone cement to reduce 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 minimize wear of the implant articular surfaces.Implant fracture and loosening due to cement failure has been reported.Precautions: -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 of normal healthy bone and joint tissue.-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 limitations of the reconstruction and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred.Excessive activity, trauma and weight gain may contribute to premature failure of the implant by loosening, fracture, and/or wear.Possible adverse effects: -particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid.It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant.-loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.-wear and/or deformation of articulating surfaces.Risk assessment: the event reports revision due to unknown reason.Risk management report documents the estimated residual risk associated with the device within the reported event.Failure analysis report concludes: a left oxford partial knee system was revised after approximately 2 years and 6 months of implantation due to unknown reason.Implant examination suggests that the bearing may have articulated against third body debris such as osteophytes and/or bone cement fragments, and that alignment of the components may have been sub-optimal.However, this cannot be confirmed without additional information being provided such as surgical notes, patient and activity details, as well as post-primary and pre-revision radiographs.Since the harm or reason for revision has not been be reported, a root cause cannot be determined, therefore a specific failure cause within the risk table cannot be selected for comparison.No corrective or preventive actions are deemed 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.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.

• Brand Name: OXF UNI TIB TRAY SZA LM/RL PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9863706
• MDR Text Key: 190135969
• Report Number: 3002806535-2020-00175
• Device Sequence Number: 1
• Product Code: NRA
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 154718
• Device Lot Number: 05019279388844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/22/2020
• Supplement Dates Manufacturer Received: 05/18/2020; 08/20/2020
• Supplement Dates FDA Received: 05/20/2020; 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention