MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA KNEE TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM THICKNESS; INSTRUMENT, KNEE

Model Number N/A

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant has returned the products to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the provisional shim became disassembled during sterilization.Attempts have been made, however, no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device history records were reviewed and no discrepancies were identified and the part was reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.A product evaluation was performed, but the disassembled / missing the components were not returned.During the investigation, it was discovered that ultrasonic cleaning was not addressed as a potential user need.A field action (zfa 2014-67 and z-1052-2015) were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.The device was subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that this device was manufactured prior to this design change.If any further information is found which would change oralter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: PERSONA KNEE TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM THICKNESS
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11321679
• MDR Text Key: 231634092
• Report Number: 0001822565-2021-00374
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 42527900301
• Device Lot Number: 62319857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1