MAUDE Adverse Event Report: ZIMMER INC PERSONA POROUS 2 PEGGED TRABECULAR METAL TIBIAL COMPONENT; KNEE PROSTHESIS

Catalog Number 42530007102

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).The devices remain implanted; therefore the condition of the components is unknown.The device history records could not be reviewed as the part and lot number is unknown.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.

Event Description

It is reported that the patient is experiencing restriction and pain when bending her knee.X-rays reportedly show that the implant has pulled away from the bone.Revision surgery has been scheduled for (b)(6) 2015.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is now known that the patient underwent right knee arthroplasty revision due to tibial loosening.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant product: nexgen complete knee solution standard primary patella ¿ cat.No.Not provided; lot no.62593968, femur cr nrw ¿ cat.No.42-5022-064-02; lot no.62621307, articular surface ¿ cat.No.42-5220-005-10; lot no.62342604.Reported event was confirmed by review of op notes.Review of the revision operative notes indicates that the patella and femur found to be well fixed but the tibia was found to be loose.Device history record was reviewed and no discrepancies relevant to the reported event were found.The problem with this device constitutes a "design issue" as the root cause.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

This follow-up report is being submitted to relay additional information.Visual evaluation of the returned tibial component found that its superior surface was gouged and discolored.The two pegs were still attached to the inferior surface and remnant of a foreign substance (bone cement) was uneven, especially it was not present on the hexagonal sides of the pegs 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

No further event information available at the time of this report.

• Brand Name: PERSONA POROUS 2 PEGGED TRABECULAR METAL TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5278165
• MDR Text Key: 33042978
• Report Number: 1822565-2015-02611
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 42530007102
• Device Lot Number: 62490330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided; 09/27/2017; 02/04/2019
• Supplement Dates FDA Received: 11/02/2016; 09/28/2017; 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 118