MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ADJUSTABLE VALGUS ALIGNMENT GUIDE; KNEE INSTRUMENT

Model Number N/A

Device Problems Bent (1059); Difficult To Position (1467); Difficult to Advance (2920); Difficult to Open or Close (2921)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported by the sales representative that during a right knee arthroplasty, the surgeon was unable to place instrument over the mating device.Another device was used to complete the surgery as the instrument was fractured.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: the following sections were corrected: complaint sample was evaluated and the reported event was confirmed.Adjustable valgus alignment guide was returned for evaluation.Visual evaluation found that one of the 4 prongs was bent, causing the issue stated in complaint.Signs of wear (nicks and gouges) were also observed.Dhr was reviewed and no discrepancies were found.The instrument mentioned in this complaint was manufactured prior to a previous design change to mitigate this issue.Therefore, the root cause is considered to be a previously addressed design issue.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

It is reported that during a total knee arthroplasty, the surgeon was unable to place the varus valgus guide over the intramedullary rod during case setup, as it was found to be bent and not opening properly for assembly.A second set was opened up and used to successfully complete the case.There were no patient consequences as a result of the malfunction.

• Brand Name: PERSONA ADJUSTABLE VALGUS ALIGNMENT GUIDE
• 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: 7278709
• MDR Text Key: 100510676
• Report Number: 0001822565-2018-00975
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

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 Model Number: N/A
• Device Catalogue Number: 42509900400
• Device Lot Number: 62376588
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1