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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem Joint Dislocation (2374)

Event Date 02/18/2014

Event Type  Injury  

Event Description

It was reported that patient underwent right partial knee arthroplasty on (b)(6) 2014.Subsequently, a revision procedure was performed on (b)(6) 2014 due to dislocation.All components were removed and replaced with a total knee system.

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: "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-05713 / 05714).

Manufacturer Narrative

This follow-up report is being filed to correct information.Device requested but not returned by hospital.

• Brand Name: OXF TWIN-PEG CMNTD FEMORAL XS PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET U.K. LTD; waterton industrial estate; bridgend; bridgend, south wales CF 31 3KA; UK CF 31 3KA
• 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: 3889970
• MDR Text Key: 4422934
• Report Number: 0001825034-2014-05713
• 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: 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: 06/24/2014
• 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: 161467
• Device Lot Number: 813460
• 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: 10/31/2013
• 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: 62 YR