MAUDE Adverse Event Report: ZIMMER INC PERSONA POROUS PEGGED TIBIAL COMPONENT

Catalog Number 42530007902

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It is reported that the patient was revised due to pain and possible loosening of the tibial component.

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a. One photograph was returned of the explanted tibial plate, but the device was not returned. Some bone ingrowth on the posterior portions of the distal surface of the plate with some visible ingrowth on both pegs. Both pegs were removed when the device was explanted. The anterior and central portions of the distal surface of the plate do not indicate bone ingrowth. Device history records for the tibial plate were reviewed and no deviations or anomalies were found. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. The package insert states that "loosening of the prosthetic knee components" is a known adverse effect. Product history search shows no other reports for the related part and lot combination. A definitive root cause cannot be determined with the information provided. Although a definitive root cause for this event cannot be determined, the clinical outcome is similar to a field action conducted on (b)(4) 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. This field action has been reported to the fda under (b)(4). The device in question was implanted prior to this field action.

Manufacturer Narrative

Surgical notes were received for review. Review of the primary notes confirms that the patient underwent a right total knee arthroplasty due to severe degenerative joint disease of right knee. It was stated that the final components were placed using cementless technique. Range of motion and stability were found to be excellent throughout with well-balanced gaps and acceptable tracking of the patella using a no-thumb technique. There were no intraoperative complications. Revision op-notes were received. Review of the revision notes confirms that the patient underwent revision surgery on due to aseptic loosening. The old tibial component was removed and the pegs were cut off and the device showed signs of 50% bony ingrowth and 50% fibrous. Corrective and preventive actions for the persona tm tibial field action 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Concomitant medical products: 42502806202 persona femur 62650382, 42522000611 persona articular surface fixed bearing 62643903. Complaint sample was evaluated and the reported event was confirmed. Dhr was reviewed and no discrepancies relevant to the reported event were found. Articular surface and tibial tray were returned and examination of the returned parts determined that the articular surface as gouges on the superior edges. On the inferior side there as dents and gouges near the anterior side and on one side of the dove tail feature. The tibial tray has foreign material on the inferior surface. The two pegs were found fractured off, and the two peg fractured pieces were returned. The superior surface has a few minor scratches. There was some bone ingrowth across the inferior surface with areas where ingrowth had not taken place. Complaint is confirmed because 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.

• Brand Name: PERSONA POROUS PEGGED TIBIAL COMPONENT
• 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: 4894165
• MDR Text Key: 16498768
• Report Number: 1822565-2015-01064
• 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: Health Professional,Distributor,DISTRIBUTOR,HEALTH PROF

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/02/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 42530007902
• Device LOT Number: 62576919
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient TREATMENT DATA

Date Received: 07/02/2015 Patient Sequence Number: 1