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

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

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.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.This report is 2 of 2 mdrs filed for the same patient (reference 3002806535-2016-00686 & 00687).

Event Description

Patient reported having been indicated for a left knee revision allegedly due to pain, unspecified skin reactions, swelling of extremities, knees, feet and groin, and yellow nail syndrome.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

• Brand Name: UNKNOWN OXFORD PARTIAL 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: 5896168
• MDR Text Key: 52746719
• Report Number: 3002806535-2016-00686
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• 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?: No
• Date Manufacturer Received: 07/25/2016
• 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): Required Intervention
• Patient Age: 69 YR