MAUDE Adverse Event Report: ZIMMER INC PERSONA TM 2 PEG TIBIAL COMPONENT; OIY

Model Number N/A

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Pain (1994); Fibrosis (3167); No Information (3190)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is experiencing pain and having difficulty moving around.A revision surgery is scheduled.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to pain and loosening.

Manufacturer Narrative

No product was returned; therefore, the condition of the trabecular metal (tm) tibial implant is unknown and visual and dimensional evaluations could not be performed.The device history records for product part and lot combination were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.The knee compatibility matrix was reviewed and identified that all the components were compatible.This device is used for treatment.A complaint history search identified no other complaint for the part/lot combination of the tibial component.The primary surgical notes state that the patient underwent total knee arthroplasty (tka) to treat severe degenerative joint disease of the left knee.The patient required deep medial collateral ligament release to facilitate acceptable extension and flexion.After implementation of the final components, range of motion and stability were found to be excellent with well-balanced gaps and acceptable tracking of the patella.No-intra-operative complications were noted.The revision surgical notes state that the patient was revised for mechanical loosening of the recalled tibial component.Surgeon reported that the backside of the tibial component had 50% bony ingrowth and the remaining appeared fibrous.A field action was conducted on (b)(6) 2015 in which zimmer voluntarily removed the persona tm 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.Fda recall contains the related tibial lot number.The corrective actions 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 TM 2 PEG TIBIAL COMPONENT
• Type of Device: OIY
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5523396
• MDR Text Key: 41069750
• Report Number: 1822565-2016-00775
• Device Sequence Number: 1
• Product Code: OIY
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 42530007101
• Device Lot Number: 62576918
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2014
• 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; Other; Required Intervention
• Patient Age: 55 YR