MAUDE Adverse Event Report: ZIMMER, INC. PERSONA POROUS TWO PEG TIBIAL COMPONENT; OIY

Catalog Number 42530006701

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

Patient Problems Pain (1994); No Information (3190)

Event Date 11/10/2015

Event Type  Injury  

Event Description

It is reported that the patient is experiencing problems with the implant and will require revision surgery.

Manufacturer Narrative

Device history records could not be reviewed as the part and lot numbers are unk.No devices or photos were rec'd; therefore, the condition of the components is unk.This device is used for treatment.Surgical notes were not provided; it is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.

Manufacturer Narrative

Review of the device history records for the tibial component identified no deviations or anomalies.A product history search identified no other complaints for the part and lot combination of the tibial component.A field action was conducted on (b)(6) 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 the patient was revised due to tibial loosening.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant devices - persona trabecular metal cruciate retaining narrow porous femoral component catalog #: 42502205801 lot #: 62467473, persona fixed bearing ultracongruent articular surface 10mm left catalog #: 42512200410 lot #: 62334527.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision to address tibial component loosening approximately two (2) years post-operatively.The patient's revision operative notes indicate that the femoral and patellar components were well-affixed and not removed.When the tibial component was removed, fifty (50) percent of the backside of the tibia appeared to be fibrous ingrowth.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A tibial component was returned for review.Visual inspection of the tibial component identified nicks and gouges on the surface of the device.Bone cement remains are noted on the distal surface of the device.Both the pegs have been cut off.Patient medical records were reviewed.X-ray review confirms that the components are anatomically aligned.No loosening, subluxation identified.Root cause remains attributed to design issue z-1266-2015.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

No further information available at the time of this reporting.

• Brand Name: PERSONA POROUS TWO PEG TIBIAL COMPONENT
• Type of Device: OIY
• 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: 4877579
• MDR Text Key: 5866304
• Report Number: 1822565-2015-01013
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2019

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: 05/31/2023
• Device Catalogue Number: 42530006701
• Device Lot Number: 62361167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/26/2015
• Supplement Dates Manufacturer Received: Not provided; 11/28/2018; 06/12/2019
• Supplement Dates FDA Received: 12/08/2015; 12/11/2018; 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2013
• 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; Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 86