MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FINN MOD RESURF FMRL RT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Damage to Ligament(s) (1952); No Code Available (3191)

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 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 warnings, it states, ¿improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.¿ this report is number 2 of 2 mdr's filed for the same event (reference 1825034-2015-04953 / 04954).

Event Description

It was reported that patient underwent a right orthopedic salvage system procedure on (b)(6) 2002.Subsequently, patient was revised on (b)(6) 2009 due to unknown reasons.During the procedure the poly components were removed and replaced.A future revision procedure as been indicated due to hyperextension issues; however, a second revision has not been reported at this time.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Remains implanted.

Event Description

It was reported that patient underwent a right orthopedic salvage system procedure on (b)(6) 2002.Subsequently, patient was revised on (b)(6) 2009 due to hyperextension issues.During the procedure the poly components were removed and replaced.A future revision procedure as been indicated due to hyperextension issues; however, a second revision has not been reported at this time.No further information has been provided.

• Brand Name: FINN MOD RESURF FMRL RT
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5285514
• MDR Text Key: 33238317
• Report Number: 0001825034-2015-04954
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK910877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 153801
• Device Lot Number: 674340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2002
• 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