MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL RIGHT MEDIAL TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) (b)(6) customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported that the patient's tibia plateau fractured when surgeon was trialling.No additional patient consequences were reported.

Manufacturer Narrative

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.

Event Description

It was further reported the cause of the problem was from the patient falling on the stairs at her residence.Subsequently, the patient underwent a revision procedure approximately three months post-implantation.It was further noted that during the revision procedure, the tibial component was well fixed; however, a piece of the patient's bone fractured away from the rest of the tibia.The tibial component was removed and replaced in addition to a tibial augment implanted.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Reported event was confirmed from x-rays received.No devices or photos were received; therefore the condition of the components is unknown.Review of x-ray review report from mmi states that there is lucency along the cement interface of the tibial component.Linear ossific densities along the anterior and posterior tibia.Rounded ossific densities along the medial aspect of the joint space are nonspecific and could represent calcified loose bodies, fracture fragments, or even loose cement within the joint space.Root cause cannot be determined as the cause of the fall is unknown.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: PERSONA PARTIAL RIGHT MEDIAL TIBIAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7302327
• MDR Text Key: 101132825
• Report Number: 0001825034-2018-01485
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2018

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 Model Number: N/A
• Device Catalogue Number: 42538000402
• Device Lot Number: 63610814
• Other Device ID Number: (01)00880304812673
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 02/21/2018; 09/12/2018
• Supplement Dates FDA Received: 03/19/2018; 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention