MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CEMENTLESS TIBIA D RM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review manufacturing history was not provided.Concomitant products: 161475 lot 2407054 oxford twin peg cementless femoral, 159583 lot 377130 oxford anatomical bearing right.

Event Description

Patient reported experiencing right knee pain, discomfort and radiolucency near tibial component.No revision procedure has been reported to date.

• Brand Name: OXFORD CEMENTLESS TIBIA D RM
• 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: 6210545
• MDR Text Key: 63427937
• Report Number: 3002806535-2016-00921
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: US166577
• Device Lot Number: 3050481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 60 YR
• Patient Weight: 102