MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DYNAMIC COMP PLATE SS 11 HOLE; CERCLAGE, FIXATION

Model Number N/A

Device Problem Bent (1059)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 07/23/2014

Event Type  Injury  

Event Description

It was reported patient underwent a left knee revision procedure on (b)(6) 2014.Subsequently, patient was further revised on (b)(6) 2014 due to a bent plate.Review of radiographs revealed a possible bone fracture and confirmed a bent plate.

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 2 states, "bending or fracture of the implant.".

Manufacturer Narrative

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

Event Description

It was reported patient underwent a left knee revision procedure on (b)(6) 2014.Subsequently, patient was further revised on (b)(6) 2014 due to a bent plate.Review of radiographs revealed a possible bone fracture and confirmed a bent plate.Additional information received noted the patient was revised on (b)(6), 2014 due to a bone fracture after a patient fall.

• Brand Name: DYNAMIC COMP PLATE SS 11 HOLE
• Type of Device: CERCLAGE, FIXATION
• 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: 4023112
• MDR Text Key: 4879832
• Report Number: 0001825034-2014-07198
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK982545
• 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: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 350821
• Device Lot Number: 604170
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2007
• 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