MAUDE Adverse Event Report: ZIMMER, INC. - BUILDING 5 PERSONA POROUS TWO PEG TIBIAL COMPONENT; KNEE PROTHESIS

Catalog Number 42530007902

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is experiencing post-operative subsidence.

Manufacturer Narrative

No devices were received for exam; therefore, the condition of the components is unknown.Review of the device history records for the tibial component identified no deviations or anomalies.The knee component matrix reviewed all components for compatibility and found no issues.This device is used for treatment.A product history search identified no other complaints for the part and lot combination of the tibial component.Primary operative notes state the patient underwent right total knee arthroplasty (tka) due to osteoarthritis.It was noted that all components were implanted with a cementless technique.The tibial component was noted to have excellent purchase within the bone.Excellent stability, 0 through 130 degrees of flexion, and no ligamentous laxity through a full range of motion were noted with the final components.No intraoperative complications were noted.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.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.

• Brand Name: PERSONA POROUS TWO PEG TIBIAL COMPONENT
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5595089
• MDR Text Key: 43272291
• Report Number: 0001822565-2016-01266
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 42530007902
• Device Lot Number: 62471377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2013
• 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): Other
• Patient Weight: 107