MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD PARTIAL TNBN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Synovitis (2094)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Date implanted - 2008.This device is not cleared for distribution in the united states; however, this report is being filed as zimmer biomet manufactures a similar device in the united states under pma number p010014.Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.

Event Description

Patient underwent a revision of a unilateral knee prosthesis approximately eight years post implantation due to pain and synovitis.During the procedure, wear of the component coating and tibial plateau was noted.

• Brand Name: UNKNOWN OXFORD PARTIAL TNBN KNEE
• 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: 6020449
• MDR Text Key: 57083226
• Report Number: 3002806535-2016-00781
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/12/2016
• 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): Hospitalization; Required Intervention