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

Model Number N/A

Device Problems Fracture (1260); Component Missing (2306)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: persona constrained tibial articular surface provisional shim, catalog # 42527900200, lot # 62400298.The complaint device has been returned, but the device investigation has not yet been completed.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018-01298.

Event Description

It was reported that the device was noticed to be fractured, worn, and missing a ball bearing.No adverse events were reported with this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Product was returned and visual examination of the returned parts shows signs of repeated use and missing ball bearings.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The root cause of the reported issue is attributed to design deficiency.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.

• Brand Name: PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7315898
• MDR Text Key: 101618941
• Report Number: 0001822565-2018-01299
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• 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: 42527900400
• Device Lot Number: 62383735
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1