MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TM TWO-PEG POROUS FIXED BEARING TIBIA LEFT SIZE E; PROSTHESIS, KNEE

Catalog Number 42530007101

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 02/16/2016

Event Type  Injury  

Event Description

It is reported that the patient is experiencing loosening.

Manufacturer Narrative

(b)(4).The part and lot numbers are unknown; therefore the device history records could not be reviewed.No devices or photos were received; therefore the condition of the components is unknown.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: - persona tm narrow porous femoral, catalog #: 42502206001, lot #: 62737836.Nexgen tm standard primary patella, catalog #: 00587806535, lot #: 62640404.Persona articular surface fixed bearing, catalog #: 42512000510, lot #: 62720692.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

It has now been reported that following a total knee arthroplasty, the patient underwent a tibial revision due to loosening.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of op notes.The revision operative notes were provided as well.The revision procedure was indicated for mechanical loosening of the tibial component.It was noted that the femoral and patellar components were well-fixed and were not removed.The tibial component was removed and it was noted that 50% of the tibial plate had ingrowth while the other half did not.Device history record was reviewed and no discrepancies relevant to the reported event were found.The design of the device is the root cause of the event.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 TM TWO-PEG POROUS FIXED BEARING TIBIA LEFT SIZE E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; p.o. box 708; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 4801137
• MDR Text Key: 5835985
• Report Number: 1822565-2015-00767
• 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: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• 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 Catalogue Number: 42530007101
• Device Lot Number: 62495347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 86