MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS MEN BEARING UHMWPE LARGE SZ 4; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.The following could not be completed with the limited information provided: date of event - ni, date explanted - ni, (b)(6).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, "early or late postoperative, infection, and allergic reaction." this report is number 1 of 3 mdrs filed for the same patient (reference 3002806535-2016-00424 / 00425 & 1825034-2016-02433).

Event Description

Information was received based on review of a journal article titled, "multi-center study of 825 phase iii oxford medial compartmental arthroplasty knees: an average ten-year survival analysis in the united states." which aimed to examine the first long-term survivorship with a large patient sample size study in the united states looking at various aspects of the phase iii oxford design while also addressing recent advancements that can help aid the uka process and improve partial knee survivorship.A patient was identified that underwent a right partial knee arthroplasty.Patient follow-up results provided at one year post-implantation indicates the patient underwent a revision procedure due to infection.

• Brand Name: OXFORD PKS MEN BEARING UHMWPE LARGE SZ 4
• 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: daniel tilbury ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5762213
• MDR Text Key: 48563232
• Report Number: 3002806535-2016-00424
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 154635
• Device Lot Number: 1164475
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2006
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 90