MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TIBIA TRABECULAR METAL FIXED BEARING RIGHT SIZE F; PROSTHESIS, KNEE

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 05/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 42502207002, femur trabecular metal cruciate retaining (cr) narrow porous, lot # 71794257, catalog #: 42522200510, articular surface fixed bearing ultracongruent (uc) right 10 mm height, lot # 62277120, catalog #: 42540000038, all poly patella cemented 38 mm diameter, lot # 62666612, catalog #: 42502207002, persona femur trabecular metal cruciate retaining narrow porous right size 11, lot # 62639674, catalog #: 00597909541, patella reamer blade with pilot hole 41 mm diameter single use only, lot # 62740784, catalog #: 20807000202, persona jigs aref & tibia rotation right, lot # 62885678, catalog #: 200100000, universal disposable drill and pin set 3 in pins(4), 5 in pin(1), 5 in drill(1), lot # 62885678.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-03849-1.Product location unknown.

Event Description

It was reported that patient underwent a revision procedure due to aseptic loosening approximately six months post implantation.It was noted that the patella was well fixed, femoral component was not grossly loose, but was easily removed, and the tibial component was grossly loose.The patient had a preoperative flexion contracture of around 20 degrees.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.The reported event is confirmed; operative notes of revision surgery identified that tibial components was grossly loose, and there was no infection evidence.The patient also had preoperative flexion contracture of around 20 degree so the femoral component was also revised.During the surgery, it was observed that femoral component was not grossly loose.No devices or photos were received; therefore, the visual and dimensional evaluations could not be performed.Device history record  (dhr) was reviewed and no discrepancies relevant to the reported event were found.Compatibility of the following components was assessed with no issues identified.A field action was conducted 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 capa investigation determined that the likely root cause as previously addressed 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

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 TIBIA TRABECULAR METAL FIXED BEARING RIGHT SIZE F
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• 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: 6744275
• MDR Text Key: 81060272
• Report Number: 0001822565-2017-05173
• Device Sequence Number: 1
• Product Code: MBH
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42530007502
• Device Lot Number: 62519942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR