MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ B RM; KNEE PROTHESIS

Model Number N/A

Device Problems Fracture (1260); Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report source, foreign - event occurred in (b)(6).We do not know at this stage whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Approx 3 weeks post surgery, patient reported sudden onset of pain in knee.X-ray showed medial tibial plateau fracture.Subsequently, the patient had the fracture reduced and the oxford prosthesis revised.

Manufacturer Narrative

(b)(4).G3: report source, foreign - event occurred in united kingdom.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Two pre-revision radiographs, taken on an unknown date, were provided for analysis with cmp-0591656: one anteroposterior and one mediolateral.The fractured tibial plateau is visible in both x-rays, with the oxford tibial tray and anatomical bearing being outside their optimum position.The femoral component appears adequately sized and positioned.The zimmer biomet product experience report (zper) states that it is unknown whether the surgical technique for the product was used and whether there were any contributing conditions related to the event.However, email communications with andrew clyde (key account manager ¿ ne) reveal that the surgeon is aware of the surgical procedure and has been trained to the required standard and that there were no contributing conditions related to the event.It has been reported that sub-optimal tibial plateau preparation and tibial tray size selection may lead to tibial fracture and tibial tray subsidence in oxford cementless systems.However, it is not possible to determine the cause of the tibial plateau fracture in this instance without provision of post-primary radiographs and further information, such as patient details (height, weight, activity level, etc.), surgical notes and the analysis of the revised components.The manufacturing history record (mhr) for the oxford partial knee tibial tray has been checked and verifies that the component was manufactured and sterilised in accordance with the applicable specifications.The mhrs for the oxford partial knee femoral component and anatomical bearing could not be checked because their part and lot numbers were not provided with the complaint at the time of writing this assessment.A review of the complaint database over the last 3 years has found 2 similar complaints reported with these items.No trend identified.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: risk management file documents the estimated residual risk associated with this device.The complaint details report that a revision procedure was carried out as a result of tibial fracture.X-rays supplied have been reviewed and the root cause for the tibial fracture can not be determined with the information provided.Since the root cause could not be determined, a line related to a specific hazard could not be selected.However, the harm of bone fracture is documented as a potential outcome of a number of hazards within the i/o table.The associated severity score is 3 which as per the severity table within the rmr is defined as moderate: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure since the complaint reports revision surgery, the outcome is considered to be within the severity associated with the harm of bone fracture.If further information about the root cause of the bone fracture is provided, risk assessment should be re-conducted.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.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2020.Subsequently, the patient reported sudden onset of pain in knee.The x-ray showed medial tibial plateau had fracture.The patient had the fracture reduced and the oxford prosthesis revised on (b)(6) 2020.

• Brand Name: OXF UNI CMNTLS TIB SZ B RM
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9927577
• MDR Text Key: 196550850
• Report Number: 3002806535-2020-00212
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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: 166573
• Device Lot Number: 6675651
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2020
• 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