MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEMORAL MD PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Swelling (2091)

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 or deviation.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." number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." number 20 states, "persistent pain." this report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Event Description

It was reported by the patient that they underwent a left partial knee arthroplasty on (b)(6) 2014.Subsequently, a revision procedure has been indicated due to pain, swelling, and radiograph indications of loosening; however, no revision procedure has been reported to date.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

• Brand Name: OXF TWIN-PEG CMNTD FEMORAL MD PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estate; bridgend, south wales
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5051392
• MDR Text Key: 24883327
• Report Number: 0001825034-2015-03801
• 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: consumer
• Reporter Occupation: Patient
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 161469
• Device Lot Number: 867060
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• 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
• Patient Outcome(s): Required Intervention