MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the device fractured while trialing during procedure.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch. 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. Updated: correction: should be reported as (b)(6)2018 in mdr # 0001822565-2018-06691 other text : discarded.

Event Description

No additional information received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device was not returned. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Reported information states that the surgeon was using a mallet to impact the tasp. The persona surgical technique (97-5026-001-00, rev 11) instructs to apply gentle manual pressure without impacting the tasp construct with either a mallet or hand. The root cause is considered to be misuse as the surgeon impacted the tasp. 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 CPS TIBIAL ARTICULAR SURFACE PROVISIONAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8130558
• MDR Text Key: 129247950
• Report Number: 0001822565-2018-06691
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 42527600510
• Device Lot Number: 62342528
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 12/04/2018 Patient Sequence Number: 1