MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI CEMENTLESS TIBIAL TRAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 166573 oxf uni cmntls tib sz b rm lot 3949370.154925 oxford ph3 cementless fem sz s lot 3930755.159572 oxf anat brg rt sm size 7 pma lot 2929321.(b)(4).Report source- foreign.The event occurred in (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 the patients' knee went into varus post total knee arthroplasty.Post-op x-ray identified a tibial fracture.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: OXFORD UNI CEMENTLESS TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7048298
• MDR Text Key: 92620888
• Report Number: 3002806535-2017-01055
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 166573
• Device Lot Number: 3949370
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other