MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TWO PEG POROUS TIBIAL COMPONENT KNEE PROSTHESIS

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 42500006001, persona femoral cemented component, lot 62467002; 42509902525, persona hex screw, lot 62408428; 42509902548, persona hex screw, lot 62453584; 42540000032, persona all poly patella, lot 62446572; 42512400511, persona articular surface, lot 62377566; 00111314001, palacos rg bone cement, lot 78284383 qty. 2.

Event Description

It is reported that the patient was revised for tibial loosening after a total knee arthroplasty revision surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of revision operative notes. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Zimmer voluntarily removed the persona trabecular metal tibial implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening. The device in question was implanted prior to this field action. The investigation determined that the likely root causes for the higher than anticipated complaint rate are that the persona tm tibia allows the potential for the tibial implant to sit proud on the resected tibial surface and the persona tm tibia has less initial stability than predicate devices. Therefore, the root cause is tied with the design of the device. 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 is reported that the patient underwent left total knee revision surgery due to tibial loosening and pain. All component were revised and a stem extension was implanted. No further information has been provided.

• Brand Name: PERSONA TWO PEG POROUS TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6175366
• Report Number: 0001822565-2016-04663
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 42530006701
• Device Lot Number: 62452076
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1266-2015
• Patient Outcome(s): Hospitalization; Required Intervention