MAUDE Adverse Event Report: ZIMMER INC PERSONA POROUS 2 PEG TIBIAL COMPONENT

Catalog Number 42530007102

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problem Pain (1994)

Event Date 08/31/2015

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 pain.A revision surgery is planned.

Manufacturer Narrative

No devices or photos were received; therefore the condition of the components is unknown.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.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 z-1266-2015 contains the related tibial lot number.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.

Event Description

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

Manufacturer Narrative

Investigation of this incident is currently ongoing.A follow-up/final report will be submitted when additional information becomes available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of patient's operative reports.Dhr was reviewed and no discrepancies relevant to the reported event were found.The revision operative notes indicate that the femoral and patellar components were in excellent condition, well fixed, therefore left alone.Tibial component was removed by using various saws at the bone implant interface.50% of the back side of the implant was covered with fibrous tissue and 50% with bony ingrowth.It appeared that 1 peg and good bone ingrowth, the other one had a lot of fibrous tissue.Visual inspection of the returned tibia shows presence foreign material (bone growth/bone cement) on it.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.

Event Description

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

• Brand Name: PERSONA POROUS 2 PEG 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: 4994651
• MDR Text Key: 22873843
• Report Number: 1822565-2015-01424
• 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: company representative,consum
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Followup,Followup,Followup
• Report Date: 11/01/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 42530007102
• Device Lot Number: 62268128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• Supplement Dates Manufacturer Received: Not provided; 10/13/2017; 10/17/2018
• Supplement Dates FDA Received: 04/07/2017; 10/14/2017; 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 77