MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE E 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign: (b)(6).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon identified damage on the surface of the implant prior to implanting it and opted not to use the device.Another device was used to complete the procedure.No adverse events were reported as a result of this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed through visual inspection.The returned articular surface exhibited nicks, gouges and scratches on the surface.The device history records were reviewed and no discrepancies relevant to the reported event 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g4; g6; h1; h2 upon reassessment of the reported event, it was determined to no longer be reportable as there no serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial reports should be voided.

Event Description

Upon reassessment of the reported event, it was determined to no longer be reportable as there no serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial reports should be voided.No new reports will be submitted under biomet as the event is not reportable.

• Brand Name: PERSONA PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE E 8 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8749562
• MDR Text Key: 149680170
• Report Number: 0001825034-2019-02814
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42518200508
• Device Lot Number: 64090485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1