MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TRABECULAR METAL TIBIAL COMPONENT; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

The following sections could not be completed with the limited information provided: persona all poly patella, catalogue # 42540200032, lot # 62826589.

Event Description

It is reported that the patient underwent revision to the left knee due to a recalled implant.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant products: item 42502807001, persona cr femoral component, lot 62614834; item 42512200612, persona ultra congruent articular surface, lot 62615003.

Event Description

It was reported patient was revised due to tibial loosening.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant medical products: 00111214001, palacos r 1x40 single, lot 78264383; 00111214001, palacos r 1x40 single, lot 78264387.This is 1 of 2 for this patient: reference (b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Primary operative note showed severe osteoarthritis knee.Patient obtained stable knee and appropriate range of motion (0 to 130 degree) with no valgus or varus.Operative note for revision states that tibia plate has been revised on (b)(6) 2016 due to mechanical loosening on left tibia.A field action was conducted on february 19, 2015 in which 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 related tibial lot number is contained in the reported field action.Corrective action investigation determined that the likely root causes for the higher than anticipated complaint rate is 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.From aforementioned information, root cause can be identified as previous design issue.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.

Manufacturer Narrative

The tibial plate and the bearing were returned for further evaluation.Visual inspection of the tibial plate found a smudge on the medial proximal surface of the plate with minor scratches across the proximal surface.There is bony material within the trabecular metal of the primarily on the lateral side with minimal to no bone on the medial side.The returned bearing is noted to having flared dovetails.The return of the device does not change the previously established root cause of design issue.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 TRABECULAR METAL 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: 6142786
• MDR Text Key: 61395567
• Report Number: 0001822565-2016-04391
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42530007901
• Device Lot Number: 62500357
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR