MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TRABECULAR METAL 2 PEGGED POROUS TIBIAL COMPONENT; KNEE PROSTHESIS

Catalog Number 42530007901

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 11/20/2015

Event Type  No Answer Provided  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient underwent knee arthroplasty revision due to tibial loosening.

Manufacturer Narrative

Concomitant medical product - part# 42512000612 articular surface fixed bearing cruciate retaining (cr) left 12 mm height, lot# 62301980, part# 42502806401 femur trabecular metal cruciate retaining (cr) standard porous lot# 62357611, part# 00587806538 nexgen complete knee solution, trabecular metal standard primary patella lot# 62655062.Persona porous 2-peg tibial component left size g was not returned with the complaint for review; therefore the condition of the components is unknown.Review of the device history records did not find any deviations or anomalies.The device is used for treatment.Review of the total knee arthroplasty operative report confirms that the patient underwent a left total knee arthroplasty on (b)(6) 2014, due to degenerative arthritis of the knee.It was stated in the report that there were no complications and the patient was in good condition after the procedure.Subsequently the patient underwent revision surgery on (b)(6) 2015 due to a failed left total knee arthroplasty with a loose tibial implant.The revision operative report stated that there was significant scarring, particularly in the infrapatellar area.It also stated that the tibial component was not grossly loose, but the trabecular metal pegs had essentially no ingrowth.A new tibial component was implanted, along with a larger poly.These components provided a good range of motion and excellent tracking and balancing with no complications noted.A complaint search for the tibial component part and lot combination revealed zero similar complaints.Products were assessed for compatibility and found to be compatible.A field action was conducted of (b)(6) 2015 in which zimmer voluntarily removed the persona trabecular metal implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening.The device in question was manufactured prior to this field action.Fda recall contains the related tibial lot number.The investigation determined that the likely root causes for the higher than anticipated complaint rate is 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 predicated devices.The root cause is considered to be the design issue.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision operative notes.Revision operative notes stated that the tibial component was not grossly loose, but the trabecular metal pegs had essentially no ingrowth.Third party review of x-rays reported the fit and alignment of left total knee arthroplasty components is standard and the none quality is normal.A thin (<2 mm) linear radiolucency at the tibial component metal tray and peg bone interfaces was confirmed on lateral x-rays 8 months post-surgery.However, such thin radiolucency at the metal bone interface is not specific for loosening as it may occur postoperatively and may be normal.Dhr was reviewed and no discrepancies relevant to the reported event were found.A field action was conducted 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.The capa 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.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.

Manufacturer Narrative

Reported event was confirmed by review of revision operative notes.Product was returned and dimensional analysis performed and correct size verified.Foreign material was noted around the pegs and posteriorly in the tm material.Revision operative notes stated that the tibial component was not grossly loose, but the trabecular metal pegs had essentially no ingrowth.Third party review of x-rays reported the fit and alignment of left total knee arthroplasty components is standard and the none quality is normal.A thin (<2 mm) linear radiolucency at the tibial component metal tray and peg bone interfaces was confirmed on lateral x-rays 8 months post-surgery.However, such thin radiolucency at the metal bone interface is not specific for loosening as it may occur postoperatively and may be normal.Dhr was reviewed and no discrepancies relevant to the reported event were found.A field action was conducted 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.The capa 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.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.

Manufacturer Narrative

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 TRABECULAR METAL 2 PEGGED POROUS 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: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6061902
• MDR Text Key: 58598576
• Report Number: 0001822565-2016-03833
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42530007901
• Device Lot Number: 62641850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2014
• Is the Device Single Use?: No
• 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: 65 YR