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

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 10/07/2015

Event Type  Injury  

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 pain, extreme swelling and instability.The patient has also undergone several knee procedures to remove scar tissue.

Manufacturer Narrative

Supplemental information including hospital records was reviewed.The primary surgical notes indicate that the patient underwent tka to treat severe advanced degenerative osteoarthritis of the right knee.With the trial components in place, the knee range of motion was 0-130 degrees of flexion, there was no varus, valgus, or anterior/posterior (ap) instability, the flexion and extension gaps matched perfectly, and the patella tracked perfectly well.After copious irrigation, the final components were press-fit in.Range of motion and stability were checked and found unchanged with respect to previous trial.Other surgical notes indicate that 4-5 weeks post-surgery the patient underwent a manipulation of the arthrofibrotic knee to increase flexion from 20 to 115 degrees.No varus, valgus, or ap instability was noted.Also, seven months post-surgery the patient underwent arthroscopy of the right knee with scar tissue debridement.Both femoral condyles as well as the articular surface were found to be intact.There was a great deal of scar tissue in the intercondylar notch and anteriorly, which was shaved off.Finally, the patient underwent yet another surgery 3 months later to excise a great deal of scar tissue from the medial and lateral gutters, and the from the suprapatellar area.There was no evidence of infection.Knee range of motion was 0-120 degrees of flexion after debridement.No varus, valgus, or ap instability, flexion and extension gaps were matched perfectly, and the patella tracked perfectly well.Per the package insert of the femoral component, pain, swelling, and a poor range of motion are known adverse effects of this procedure.A product history search identified 0 other complaint for the part and lot combinations of femoral component.Upon review of this supplemental information the previous conclusions remain unchanged.

Manufacturer Narrative

Review of the revision op notes that occurred on (b)(6) 2015 indicates that the patient underwent a revision for aseptic loosening.It was stated that there was no ingrowth on the tibial component when it was removed.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.Therefore, the problem with this device constitutes a "design issue" as the root cause.

• Brand Name: PERSONA POROUS TWO PEGGED 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5952978
• MDR Text Key: 54809287
• Report Number: 0001822565-2016-03269
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• 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
• Report Date: 08/18/2016

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42530007902
• Device Lot Number: 62452050
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/12/2016; 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2013
• 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: 46 YR
• Patient Weight: 75