MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 4 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in progress.Once the investigation has been completed a follow-up mdr will be submitted.

Event Description

Revision due to lateral progression.

Event Description

Revision due to instability and lateral progression.

Manufacturer Narrative

(b)(4).X-ray evaluation: immediate post-primary radiographs are required in order to fully assess the initial sizing and positioning of the components.On the antero-posterior radiograph taken on 11-jun-2014, a gap is visible between the vertical wall of the tibial tray and bone.The oxford surgical technique recommends that the lateral fit of the vertical wall should be flush with the bone.The position of the x-ray marker wire and medial ball indicate that the polyethylene bearing may have been slightly overhanging the medial edge of the tibial tray; the oxford surgical technique recommends the x-ray marker wire to be central and parallel with the tibial component.In the medio-lateral radiograph, also taken on (b)(6) 2014, the tibial tray appears to be sized and positioned in accordance with the guidelines in the oxford surgical technique.The femoral component is overhanging the posterior edge of the femoral condyle.A portion of bone cement is visible on the posterior edge of the femoral component that is not contacting bone.This can be observed also on some of the later radiographs, taken on (b)(6) 2015, (b)(6) 2018.The oxford surgical technique recommends that the femoral component should be flush with, or have less than 4 mm overhang from the posterior edge of the femoral condyle.The indicated reason for the bearing exchange was 'polyethylene had some impingement related oxidation.We noted laxity medially and 4 mm bearing was replaced with a 6 mm bearing'.The meniscal bearing has not been received for examination and therefore the report of impingementrelated oxidation cannot be confirmed.It is also unclear at which point the patient has developed joint laxity, as surgical notes from the primary procedure have not been provided.The review of the deviation report does not identify any deviations associated with the lot numbers associated with this complaint.For item/lot combination of 161468/145410, review of deviation history states that 4 units deviated due to cosmetic reasons.They were reworked and accepted.The root cause of revision cannot be determined in this instance without further information, including surgical notes from the primary procedure and provision of the revised meniscal bearing.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

Revision due to instability and lateral progression.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: OXF ANAT BRG LT SM SIZE 4 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8353003
• MDR Text Key: 136590391
• Report Number: 3002806535-2019-00124
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 159541
• Device Lot Number: 948220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• 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 Weight: 68