MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA VIVACIT-E FIXED BEARING POSTERIOR STABILIZED ARTICULAR SURFACE 10MM LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Damage to Ligament(s) (1952)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: persona natural stemmed cemented tibial component 5 degree left size e catalog #: 42532007101 lot #: 63573117, persona cemented posterior stabilized narrow femoral component left size 9 catalog #: 42500006601 lot #: 63557588, persona tapered cemented stem extension 14mm x 30mm catalog #: 42557000114 lot #: 63589350.It is indicated by the complainant that the devices will not be returned to zimmer biomet for investigation, as the devices are not available.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned by patient.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision to replace the polyethylene articular surface to address dissymmetry of the medial collateral and lateral collateral ligaments.A thicker articular surface was placed for the loose lateral collateral ligament.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.Per package insert for the persona personalized knee system, instability is a known adverse effect of this procedure.However, a definitive root cause could not be determined as it is unknown if the asymmetrical ligaments are a patient condition or a result of the knee procedure.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 event information available at the time of this report.

• Brand Name: PERSONA VIVACIT-E FIXED BEARING POSTERIOR STABILIZED ARTICULAR SURFACE 10MM LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7790597
• MDR Text Key: 117343649
• Report Number: 0001822565-2018-04430
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42512400710
• Device Lot Number: 63511758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 73