MAUDE Adverse Event Report: BIOMET U.K. LTD OXF TWIN-PEG CMNTD FEM MD PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 03/31/2014

Event Type  Injury  

Event Description

It was reported patient underwent right total knee arthroplasty on (b)(6) 2014.Subsequently, patient underwent a revision procedure on (b)(6) 2014 due to pain and malpositioning of the implants.

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 warnings it states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." under possible adverse effects, number 19 states, ¿persistent pain." this report is number 2 of 3 mdrs filed for the same event (reference 1825034-2014-04728 / 04730).

Manufacturer Narrative

This follow-up report is being filed to correct information.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2014-04728 / 04730).Discarded.

• Brand Name: OXF TWIN-PEG CMNTD FEM MD PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET U.K. LTD; waterton industrial estate; bridgend; south wales, great britain
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3828331
• MDR Text Key: 18297980
• Report Number: 0001825034-2014-04729
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPO10014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 161469
• Device Lot Number: 357090
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 36 YR