MAUDE Adverse Event Report: ZIMMER, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR PROVISIONAL SHIM SIZE EF 12MM; PROSTHESIS, KNEE

Catalog Number 42527900402

Device Problem Disassembly (1168)

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

Event Type  malfunction  

Manufacturer Narrative

Reference (b)(4).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 persona shim was found with missing ball bearings on an office shelf.No information regarding when or where these originally went missing.Attempts have been made and additional information on the reported event is unavailable at this time.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned devices show that has one of component¿s 1 and 2 disassembled / missing.None of the missing / disassembled components were returned.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.Investigation results concluded that the reported event was due 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 PROVISIONAL SHIM SIZE EF 12MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6591052
• MDR Text Key: 75966368
• Report Number: 0001822565-2017-03547
• Device Sequence Number: 1
• Product Code: MBH
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42527900402
• Device Lot Number: 62538388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/25/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2013
• 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