MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD TWIN PEG CEMENTLEES FEMORAL MD; PROSTHESIS, KNEE

Catalog Number 161474

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Synovitis (2094)

Event Date 07/02/2014

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number - cmp-(b)(4).Medical products - oxf anat brg lt md size 3 pma catalog #: 159547 lot #: 773820, and oxford cementless tibia d lm catalog #: us166576 lot #: 3050477.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00309 and 3002806535-2017-00310.

Event Description

It was reported the patient underwent a left partial knee arthroplasty.Subsequently, the patient experienced synovitis, pain, swelling and tenderness.It is unknown if the device is related to the event.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: OXFORD TWIN PEG CEMENTLEES FEMORAL MD
• 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: 6560468
• MDR Text Key: 74941679
• Report Number: 3002806535-2017-00308
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 161474
• Device Lot Number: 2409869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 138