MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 3 PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problems Degraded (1153); Material Integrity Problem (2978); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); No Information (3190)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report source.Foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.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, a revision procedure was performed due to wear.The patient is highly active in playing and coaching basketball.

Manufacturer Narrative

(b)(4) this final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.As the product has not been received, the investigation was limited to the information available.Radiographs: one anteroposterior (ap) radiograph, taken on an unknown date, has been provided with cm-0625066 for analysis.The components appear adequately sized.However, the tibial tray appears short of the medial edge of the tibial plateau.The oxford partial knee surgical technique states that the tibial tray should be flush with (or have less than 2 mm overhang from) the medial edge of the tibial plateau.Additionally, although a definite assessment cannot be made because of the suboptimal angle at which the x-ray was taken, the femoral component appears to be at a varus angle relatively to the tibial tray.The oxford partial knee surgical technique states that the varus angle should be smaller than 10 degrees.The bone density below the tibial tray also appears to be lower than in the rest of the joint.The medial side radiographic marker ball of the meniscal bearing is visible in the ap radiograph.Immediate post-primary radiographs and pre-revision mediolateral radiographs have not been provided and are needed to further investigate the reported wear of the bearing.The patient, male, was 54 at the time of revision surgery of the bearing due to wear, approximately 12 years after primary surgery in 2007/2008.The zimmer biomet product experience report (zper) states that the patient was active in playing basketball and coaching basketball.However, additional patient information such as weight and height are not available due to country regulations.The zper further states that the surgical technique for the product was utilised, and that there were no contributing conditions related to the event.It is not possible to determine the cause of bearing wear that led to its revision, but it is likely that the active lifestyle of the patient was a significant contributing factor.Although they have been requested, the manufacturing history records (mhrs) for the oxford partial knee femoral component, tibial tray and anatomical bearing could not be checked because they were not available at the time of writing this assessment.A review of the manufacturing history records was not possible as lot number is not available.Complaints search was conducted for events occurring between (b)(6) 2017 to (b)(6) 2020 for item 159554.No other complaints were identified for this item number other than (b)(4).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.Risk management report documents the estimated residual risk associated with the reported event.The reported event states revision due to wear.The associated harm for this incident has a maximum severity of 3 which is described in the severity table as: s-3 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 outcome of the reported event (surgical intervention) is considered to be within the severity of the rmf.In order to calculate the occurrence rate, sales and complaint data for these item numbers has been obtained, and is attached for a period of the last 3 years prior to the notification date, being (b)(6) 2020.Sales ((b)(6) 2017 to (b)(6) 2020) = 11869 units.Complaints search was conducted for events occurring between (b)(6) 2017 to (b)(6) 2020 for item 159554.No other complaints were identified for this item number other than (b)(4).Therefore, the calculated occurrence rate is 1 in 11869 since the occurrence calculation is based on only 1 complaint, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a calculation based on one instance of a complaint.The failure mode will be monitored through zimmer biomet internal complaint and post market surveillance activities with further review of risk conducted through these processes.-as multiple hazards (lines) result in a hazardous situation of accelerated wear, and the root cause of the above complaint has not been determined, a specific hazard (line) cannot be selected for the reported event.As a hazard cannot be selected, the occurrence score for one hazard cannot be attributed to all events, and therefore cannot be used for comparison.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 h3 other text : product has not been returned.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on an unknown date in 2007.The patient is highly active in playing and coaching basketball.Subsequently, a revision procedure due to wear was performed on (b)(6), 2020.

• Brand Name: OXF ANAT BRG LT LG SIZE 3 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: 10493740
• MDR Text Key: 205665376
• Report Number: 3002806535-2020-00408
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786008
• UDI-Public: 05019279786008
• 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
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• 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: 159554
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• 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
• Patient Age: 54 YR