MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C RM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 12/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Product has been requested to be returned, no information available at this time.Concomitant medical products: medical product: unknown oxford bearing component, catalog #: unknown, lot #: unknown.Medical product: unknown oxford femoral component, catalog #: unknown, lot #: unknown.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00039.3002806535-2021-00040.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 right knee arthroplasty on an (b)(6) 2016.Subsequently, a revision procedure due to pain and dislocation was performed on (b)(6) 2020.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on an (b)(6) 2016.Subsequently, a revision procedure due to pain and dislocation was performed on (b)(6) 2020.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00039-1, 3002806535-2021-00040-1.As the product has not been received, the investigation was limited to the information provided.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as item numbers and lot numbers are unknown.A review of the complaint history search could not be performed as item numbers and lot numbers are unknown.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00039-2, 3002806535-2021-00040-2.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 right knee arthroplasty on an (b)(6) 2016.Subsequently, a revision procedure due to pain and dislocation was performed on (b)(6) 2020.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on an (b)(6), 2016.Subsequently, a revision procedure due to pain and dislocation was performed on (b)(6), 2020.

Manufacturer Narrative

(b)(4).This final follow-up 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, complaint history and x-ray review.Fifteen radiographs have been provided with (b)(4).Five radiographs were taken before primary surgery, and three radiographs were taken after revision.Two of the post-primary radiographs were provided in duplicate, therefore five radiographs were considered relevant in this assessment: two post-primary anteroposterior (ap) radiographs (taken on (b)(6) 2017 and (b)(6) 2018), two post-primary skyline radiographs (taken on (b)(6) 2017 and (b)(6) 2018), one post-primary mediolateral (ml) radiograph (taken on (b)(6) 2018).The orientation of the knee in both post-primary ap radiographs does not allow the full assessment of the sizing, fit and positioning of components.The oxford surgical technique recommends that before taking the film, adjust the position of the limb by flexing/extending the knee and internally/externally rotating the leg until the tibial component appears on the screen directly end-on.A region of low bone density is observed below the tibial tray in both ap radiographs.The post-primary ml radiograph shows a gap between the anterior portion of the tibial tray and the tibial plateau.Uneven cement mantle is visible below the posterior portion of the tibial tray.The posterior fit of the tibial component appears to be short of the posterior edge of the tibial plateau.The oxford surgical technique recommends that the posterior fit of the tibial component should be flush or with less than 2mm overhang relative to the tibia.Immediate post primary radiographs are required to evaluate the initial sizing, fit and positioning of components.The patient (male) was 53-year-old with 5 feet 7 inches of height and 122 kg of weight (bmi 42.13, obese) at the time of the primary surgery.Patient records provided with (b)(4) inform that the patient is a smoker, and that he suffers from osteoarthritis, diabetes, lumbar degenerative disc disease, hypertension, hyponatremia and hyperlipidemia.Medical records dated (b)(6) 2016 reported that there is bone marrow edema in the proximal tibia near the tibial spine with subchondral cystic change also identified.It is stated in the complaint description that the patient was told he was getting total knee but got partial instead, not sure why.However, medical records dated (b)(6) 2016 report that he [the patient] is indicated for right knee unicompartmental arthroplasty.The risk and benefits of the procedure were explained to the patient who agrees to proceed.The reported loosening is confirmed in the provided surgical notes of the revision surgery, which state that the tibia was released, sloped a lot posteriorly.It was loose like it did not settle.The manufacturing history records (mhrs) for the oxford anatomic bearing, femoral component and tibial tray have been checked and verify that these components were manufactured and sterilized in accordance with the applicable specifications.The instructions for use provided with the oxford anatomic bearing and tibial tray and with the femoral component provide the following relevant information: 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.Implant fracture and loosening due to cement failure has been reported.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.Patient smoking may result in delayed healing, non-healing and/or compromised stability in or around the placement site.Clinical outcome may be affected by component positioning.Proper placement of the implant should take into consideration individual patient anatomy as well as surgeon preference.The surgical technique sets forth guidelines for placement of the knee system.Precautions: excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of the implant by loosening, fracture, dislocation, subluxation and/or wear.Possible adverse effects: loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.The root cause of the tibial component loosening cannot be determined without immediate post-primary x-rays and analysis of the revised components.However, sub-optimal sizing and cementing of components, the patient¿s sub-optimal bone quality, his high bmi and smoking history, and his coexisting medical conditions 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 7 complaints reported with the item (b)(4), 19 complaints reported with the item (b)(4) and 8 complaints reported with the item (b)(4) (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00039-3.3002806535-2021-00040-3.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 : device location unknown.

• Brand Name: OXF UNI TIB TRAY SZ C RM PMA
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11365005
• MDR Text Key: 233043187
• Report Number: 3002806535-2021-00041
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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: 154723
• Device Lot Number: 831920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 212