MAUDE Adverse Event Report: ZIMMER, INC. PERSONA POROUS 2 PEG TIBIAL COMPONENT; KNEE PROSTHESIS

Catalog Number 42530006702

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to a failed total knee arthroplasty involving a tibial component alleged to have been involved in a recall.

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.The device history records for the tibial component were reviewed and no deviations or anomalies were identified.A review of the compatibility matrix was performed.This device is used for treatment.The primary surgical notes state that the patient underwent tka to treat severe degenerative joint disease of the right knee.Bony cuts were performed, osteophytes removed, and the trial components were inserted.Releases of the popliteus and lateral retinaculum were required to achieve acceptable extension and flexion, well-balanced gaps, and excellent tracking of the patella.The final components were implemented using a cementless technique.Range of motion and stability were rechecked and found to be excellent with well-balanced gaps and acceptable patellar tracking.No intraoperative complication noted.The revision surgical notes state that the patient was revised 13 months post surgery due to a failed right tka associated with the recalled tibial component.Intra-operatively the synovial fluid was found clear and cultures were negative for infection.The tibial component was removed using a saw and osteotomes.Fifty percent of the tibial component appeared to have bone ingrowth and 50 percent was fibrous; the pegs were well ingrown.The femoral and patellar components were well fixed and left alone.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 capa 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 problem with this device constitutes a "design issue" as the root cause.

• Brand Name: PERSONA POROUS 2 PEG 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5729524
• MDR Text Key: 47533281
• Report Number: 0001822565-2016-02073
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 42530006702
• Device Lot Number: 62438473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2013
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR