MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MG II FLAT TIBIAL ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Concomitant medical products: mg ii patella cat#: 00511006035, lot#: 60291700.Reported event was confirmed by review of photos.Visual examination of the pictures determined that the both superior and inferior side of the articular surface and patella are damaged specially condylar surface of the articular surface.Device history record was reviewed and no discrepancies were found.Review of complaint history determined that no further action(s) is/are required.The root cause of the reported issue for the articular surface is attributed to long useful life of the device as it was reported that the device was used successfully in vivo for 18 years.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-00604, 0001822565-2018-00605.

Event Description

It was reported that the patient underwent a total knee arthroplasty revision approximately nineteen (19) years post-operatively due to polyethylene wear of the bearing.During the procedure, moderate metallosis was noted and the metal-backed patella was found damaged.

• Brand Name: MG II FLAT TIBIAL ARTICULAR SURFACE
• 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: 7247788
• MDR Text Key: 99217197
• Report Number: 0001822565-2018-00604
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK880155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00511004009
• Device Lot Number: 40858300
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/1998
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 92