MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA VIVACIT-E POSTERIOR STABILIZED ARTICULAR SURFACE 11MM RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Damage to Ligament(s) (1952)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices - unknown persona femoral component catalog #: ni lot #: ni, unknown persona tibial component catalog #: ni lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by manufacturer? investigation incomplete.

Event Description

It was reported the patient underwent a right knee arthroplasty revision to address ligamentous instability approximately two (2) years post-operatively.The articular surface was removed and replaced.It was verified by the surgeon that no additional information is available.

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.A definitive root cause could not be determined with the information provided.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 POSTERIOR STABILIZED ARTICULAR SURFACE 11MM RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10179768
• MDR Text Key: 195954321
• Report Number: 0001822565-2020-02177
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024243767
• UDI-Public: (01)00889024243767
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42522400711
• Device Lot Number: 63418220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2020
• 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