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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.

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Manufacturer (Section D)
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46581-0708
MDR Report Key4894165
MDR Text Key16498768
Report Number1822565-2015-01064
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK121771
Number of Events Reported1
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 Received07/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Catalogue Number42530007902
Device LOT Number62576919
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/25/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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