MAUDE Adverse Event Report: ZIMMER, INC. PERSONA PEGGED TM TIBIAL COMPONENT; KNEE PROSTHESIS

Catalog Number 42530007101

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Joint Disorder (2373); No Information (3190)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to an unknown reason.

Manufacturer Narrative

This report is being amended to reflect changes in adverse event and/or product problem, explant date, event problem codes, date received by mfr, type of reports, type of reportable event, if follow-up, what type?, evaluation codes, if remedial action initiated and additional mfr narrative.No devices or photographs were received with complaint for investigation; therefore, the condition of the persona two-peg trabecular metal (tm) tibia component is unknown.Without a device for exam, neither visual nor dimensional analysis are possible.The device history records review on the product part and lot numbers identified no deviations or anomalies.The knee component compatibility matrix was reviewed and identified that all components are compatible.This device is used for treatment.A complaint history search identified no other complaint for the part/lot combination of the tibial component.The primary surgical notes state that the patient underwent total knee arthroplasty (tka) to treat severe degenerative joint disease of the left knee.Bony cuts were performed, osteophytes removed, and the trial components were inserted.Release of the deep medial collateral ligament semimembranosus was required to achieve acceptable extension and flexion, well-balanced gaps, and excellent tracking of the patella.The final components were implemented using a cementless technique.Range of motion and stability were checked and found to be excellent with well-balanced gaps and acceptable patellar tracking.No intraoperative complication noted.The revision surgical notes state that the patient was revised 22 months after primary implantation to address the failure of the tka associated with the recall of the tibial component.Intra-operatively, the synovial fluid was clear.The tibial component was removed by using saws, 50% of the implant surface had the correct bony ingrowth while the remaining part was fibrous.The medial head (peg) was well fixed but not the lateral one.The femoral and patellar components were felt to be intact and left alone.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.An 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.Therefore, the problem with this device constitutes a design issue as the root cause.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product- femur trabecular metal cruciate retaining (cr) narrow porous catalog# 42502206001 lot# 62504834, nexgen® complete knee solution, trabecular metal standard primary patella catalog# 00587806532 lot# 62491597, articular surface fixed bearing cruciate retaining (cr) left 10 mm height catalog# 42512000510 lot# 62380346.The tibial tray were returned and examination of the returned parts determined that it 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 scrapes and abrasions.There was some bone ingrowth across the inferior surface with areas where ingrowth had not taken place.Dhr was reviewed and no discrepancies relevant to the reported event were found.The additional information was reviewed and it does not change the previous conclusions.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 was reported that patient was revised 22 months after primary implantation to address the failure of the tka associated with the recall of the tibial component.Review of tibial component showed signs of loosening and implant fracture.

• Brand Name: PERSONA PEGGED TM TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5729917
• MDR Text Key: 47543732
• Report Number: 0001822565-2016-02075
• Device Sequence Number: 1
• Product Code: OIY
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 42530007101
• Device Lot Number: 62365152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2013
• 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; Required Intervention
• Patient Age: 69 YR