MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL; KNEE INSTRUMENT

Model Number N/A

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation  has been completed, a follow-up mdr will be submitted.  discarded.

Event Description

It was reported that surgeon was performing a trial reduction of a persona total knee and the plastic poly provisional fractured.

Manufacturer Narrative

The reported event was confirmed as product was returned and visual examination concludes that the returned device exhibits signs of repeated use (nicked and gouged) also has fractured on the medial side of the post, all pieces were returned.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.Root cause could not be determined as frequency of use is unknown and condition of use is unknown.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 CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7214714
• MDR Text Key: 98066894
• Report Number: 0001822565-2018-00368
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42517600707
• Device Lot Number: 63010198
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1