MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CEMENTLESS TIBIA B RM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Date 11/22/2013

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4) medical product - oxford femoral component catalog#: 161473 lot#: 2409850, oxford tibial bearing catalog#: 159571 lot#: 2702005.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as a similar device is cleared for distribution in the united states under pma number p010014.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient experienced an intraoperative tibial fracture.Subsequently, the patient underwent a revision procedure due to pain and the tibial fracture approximately four months post-implantation.No additional patient consequences were reported.

• Brand Name: OXFORD CEMENTLESS TIBIA B RM
• 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: 6564854
• MDR Text Key: 75069521
• Report Number: 3002806535-2017-00368
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: US166573
• Device Lot Number: 3050464
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2013
• 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
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 75