MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM ANATOMIC ARCOM MENISCAL BEARING MEDIUM LEFT 3MM THICK; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Synovitis (2094)

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 the 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 20 states, "persistent pain." (b)(4).

Event Description

Patient reported experiencing pain and synovitis approximately three years post implantation.An arthroscopy was performed and the surgeon noted abrasion and dissolution of the implant.

• Brand Name: OXFORD PARTIAL KNEE SYSTEM ANATOMIC ARCOM MENISCAL BEARING MEDIUM LEFT 3MM THICK
• 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: 6049121
• MDR Text Key: 58128641
• Report Number: 3002806535-2016-00796
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PP010014
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 2880367
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2012
• 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