MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF UNI TIB TRAY SZA LM/RL PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

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.

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 these types of events can occur: under possible adverse effects, number 9 states, "intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device.This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2014-08188).

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Additional information: updated event description - the reason for revision was reported as being due to disease progression.

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 disease progression in which the patient was converted to a total knee.

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

(b)(4).Upon internal review, it was determined that this complaint does meet the definition of a reportable complaint.Therefore the original report for this complaint is being kept.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

• Brand Name: OXF UNI TIB TRAY SZA LM/RL PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 4182132
• MDR Text Key: 5096385
• Report Number: 0001825034-2014-08027
• 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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 154718
• Device Lot Number: 632670
• 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; 03/02/2016
• 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: 01/02/2014
• 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