MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CEMENTLESS FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 01/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - oxford cementless tibia d rm, catalog #: us166577, lot #: 3050482 and oxf anat brg rt md size 4 pma catalog #: 159576, lot #: 948700.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient underwent a right partial knee arthroplasty.Subsequently, the patient experienced crepitus approximately six months post-implantation.No revision procedure has been reported to date.

• Brand Name: OXFORD CEMENTLESS FEMORAL COMPONENT
• 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: 6549697
• MDR Text Key: 74581950
• Report Number: 3002806535-2017-00297
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 161474
• Device Lot Number: 2494942
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2011
• 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): Disability
• Patient Age: 67 YR
• Patient Weight: 97