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

Catalog Number 42530007901

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Insufficient Information (3190)

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

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is alleging harm caused by the device and requires revision; however, the nature of the harm is unknown at this time.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It has now been reported that the patient revised due to pain and possible loosening.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

Event Description

Patient underwent a left knee revision procedure approximately three years post implantation due to pain and loosening.Operative report received indicated the revision was due to mechanical loosening of the tibial component.Operative report further states that the femoral and patellar components were well fixed but the tibia was not, noting no bony growth on the tibial pegs and approximately 50% growth on the back of the tibial component.The tibia and articular surface were removed and replaced.

Manufacturer Narrative

Concomitant medical product: femur trabecular metal cruciate retaining (cr) standard porous, catalog #42502806201, lot #62347268.Articular surface fixed bearing cruciate retaining (cr) left 12 mm height, catalog #42512000612, lot #62380358.The reported event was confirmed through review of operative notes received.Operative notes from the revision surgery state that the patient was revised due to mechanical loosening of the tibial component.It was noted that the pegs appeared to have no bony ingrowth.The back side was noted to have 50% bony ingrowth and 50% fibrous ingrowth.The patellar and femoral components were noted to be well fixed and were not revised.Device history record was reviewed and no discrepancies were found.A field action was previously 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 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.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 POROUS 2 PEG TRABECULAR METAL 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: 5811896
• MDR Text Key: 50088108
• Report Number: 0001822565-2016-02528
• 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: Initial,Followup,Followup,Followup
• Report Date: 06/15/2017

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: 08/31/2023
• Device Catalogue Number: 42530007901
• Device Lot Number: 62434344
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/18/2016; 01/20/2017; 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2013
• 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): Other
• Patient Age: 64 YR