MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL COMPONENT; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in the (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the sales representative that a patient presented with a painful ukr due to a medial tibial plateau fracture.Subsequently, the patient will undergo orif on an unknown date.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.One anteroposterior radiograph: the tibial plateau is fractured in the direction of the keel of the tibial tray, and therefore it is assumed to have been taken prior to the orif surgery.It is stated in the zper that the surgical technique was followed and that the ''post op xray did not show an obvious fracture.'' no post-primary surgery radiographs were available for analysis at the time of this assessment.It is not possible to determine the cause of the tibial plateau fracture with the information available at the time of this review.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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 by the sales representative that a patient presented with a painful ukr due to a medial tibial plateau fracture.Subsequently, the patient will undergo orif on an unknown date.

• Brand Name: UNKNOWN OXFORD TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8779711
• MDR Text Key: 150683893
• Report Number: 3002806535-2019-00603
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• 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