MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF ANAT BRG LT MD SIZE 4 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arthritis (1723); Bone Fracture(s) (1870)

Event Date 08/13/2014

Event Type  Injury  

Event Description

It was reported the patient underwent an initial left partial knee arthroplasty on (b)(6) 2014.During the procedure, the patients tibia was noted to be fractured.The surgeon implanted a proximal tibial plate to address the fracture.Subsequently, the patient underwent a revision procedure on (b)(6) 2014 due to unknown reasons in which the patient was converted to a total knee.

Event Description

It was reported the patient underwent an initial left partial knee arthroplasty on (b)(6) 2014.During the procedure, the patient's tibia was noted to be fractured.The surgeon implanted a proximal tibial plate to address the fracture.Subsequently, the patient underwent a revision procedure on (b)(6) 2014 due to disease progression in which the patient was converted to a total knee.

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.This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2014- 08027 / 08188).

Manufacturer Narrative

Updated event description - the reason for revision was reported as being due to disease progression.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

It has been determined through remediation review that this is now a reportable complaint, despite the fact that it was rejected in 2016.The product was not available for return.Root cause determined to be disease progression.Conditions are addressed in the package insert.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues reported for these parts.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.Relayed results to sales rep via email on nov 24, 2014.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.(b)(4).

• Brand Name: OXF ANAT BRG LT MD SIZE 4 PMA
• 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: 4182165
• MDR Text Key: 5096389
• Report Number: 0001825034-2014-08188
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: 166550
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2014
• Initial Date FDA Received: 10/17/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/17/2014
• Supplement Dates FDA Received: 11/21/2014; 03/30/2016; 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• 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
• Patient Age: 61 YR