MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXFORD UNI TIB BRG MED SZ4; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Inflammation (1932); Burning Sensation (2146)

Event Date 06/09/2014

Event Type  Injury  

Event Description

It was reported patient underwent a bilateral total knee arthroplasty on (b)(6) 2006.Subsequently, patient underwent a right knee revision procedure on (b)(6) 2007 due to alleged inflammation and fluid.It was further reported that on (b)(6) 2014 patient underwent a revision procedure of the left knee due to loosening and burning sensation after long periods of standing.All components were removed and replaced with competitor product on (b)(6) 2014.A review of the invoice history confirmed the initial surgery date; however, an invoice could not be located to confirm the revision procedures and which components were removed and replaced.

Event Description

It was reported patient underwent a bilateral partial knee arthroplasty on (b)(6) 2006.Subsequently, patient underwent a right knee revision procedure on (b)(6) 2007 allegedly due to inflammation, swelling, pain and fluid.It was further reported that on (b)(6) 2014 patient underwent a revision procedure of the left knee due to loosening and burning sensation after long periods of standing.Components were removed and replaced with competitor product during both revision procedures.A review of the invoice history confirmed the initial surgery date; however, an invoice could not be located to confirm the revision procedures and which components were removed and replaced.

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: under possible adverse effects, number 6 states, ¿material sensitivity reactions." number 20 states, "persistent pain." this report is number 4 of 5 mdrs filed for the same event (reference 1825034-2014-05305/05308 & 05505).

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Manufacturer Narrative

This follow-up report is being filed to relay correct right knee revision procedure date.Examination of returned device found no evidence of product non-conformance.The root cause of the event could not be determined due to insufficient information.

Event Description

It was reported patient underwent a bilateral total knee arthroplasty on (b)(6) 2006.Subsequently, patient underwent a right knee revision procedure on (b)(6) 2007 allegedly due to inflammation, swelling, pain and fluid.It was further reported that on (b)(6), 2014 patient underwent a revision procedure of the left knee due to loosening and burning sensation after long periods of standing.Components were removed and replaced with competitor product during both revision procedures.A review of the invoice history confirmed the initial surgery date; however, an invoice could not be located to confirm the revision procedures and which components were removed and replaced.

• Brand Name: OXFORD UNI TIB BRG MED SZ4
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3871653
• MDR Text Key: 4570323
• Report Number: 0001825034-2014-05308
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 154627
• Device Lot Number: 166619
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2006
• 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