MAUDE Adverse Event Report: ZIMMER, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAININGRIGHT 12 MM HEIGHT; PROTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330); No Information (3190)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

No information was provided related to the type of adverse event experienced.Concomitant medical products: nexgen trabecular metal standard primary patella, item number # (b)(4) , lot #62482830.

Event Description

It was reported that a patient experienced an unknown event on an unknown date.

Manufacturer Narrative

No devices or photos were received; therefore the condition of the components is unknown.Review of the device history records for the femoral, articular surface and tibial component did not find any deviations or anomalies.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.No compatibility issues were noted.A complaint history review was performed.A definitive root cause cannot be determined with the information provided.However, the complaint may be revised upon return of product or further information.This report is number 1 of 3 mdrs filed for the same patient (reference (b)(6).

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown a the time of the initial medwatch.

Event Description

It was reported the patient underwent a right total knee arthroplasty.Subsequently, the patient underwent a revision procedure approximately twenty months post-implantation due to unknown reasons.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Concomitant medical products: natural tibia trabecular metal two-peg porous fixed bearing right size e catalog # 42530007102 lot # 62692184; femur trabecular metal cruciate retaining (cr) standard porous catalog # 42502805602 lot # 62573822.

Event Description

It was reported a patient underwent two knee manipulations under anesthesia approximately one and three months post-implant due to arthrofibrosis.Subsequently, the patient underwent a right total knee revision arthroplasty approximately thirty months post-implantation due to pain, discomfort, arthrofibrosis, aseptic loosening and radiolucent lines around the femoral component.

Manufacturer Narrative

Reported event was confirmed by review of revision operative notes.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-04730-4, 0001822565-2016-04720-4, 0001822565-2016-04731-4.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAININGRIGHT 12 MM HEIGHT
• Type of Device: PROTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): .; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6190951
• MDR Text Key: 62906003
• Report Number: 0001822565-2016-04731
• Device Sequence Number: 1
• Product Code: OIY
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 42522000512
• Device Lot Number: 62732855
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 60 YR