MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PALACOS LVG 1X40 SINGLE; BONE CEMENT, ANTIBIOTIC

Catalog Number 00111914001

Device Problem Clumping in Device or Device Ingredient (1095)

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

Event Date 06/04/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).(b)(4).Review of the receiving inspection report for 00111914001, lot number 85054569, identified no relevant deviations or anomalies.Heraeus batch record review indicates there were no quality deviations, no change notifications, and no corrective or preventive actions.All verifications, inspections, and tests were successfully completed.Product examination could not be performed as no product was returned for this complaint.This complaint cannot be confirmed.Per heraeus (alliance partner of zimmer biomet for this product), the root cause of the reported event is "presumably a result of incorrect preparation due to professionals" with a potential explanation as "inadequate mixing".The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Customer has indicated that the product will not be returned, as it remains implanted, to zimmer biomet for investigation.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.Device remains implanted.

Event Description

It was reported that the cement started to set quicker than usual, even when storage and mixing were consistent.As a result a shorter smaller stem was quickly swapped in place.An alternate product was used in the event.No adverse events were reported as a result of this malfunction.On (b)(6) 2018, the investigation of this event was completed and it was confirmed that the device would not be returned.

• Brand Name: PALACOS LVG 1X40 SINGLE
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7745291
• MDR Text Key: 115905136
• Report Number: 0001526350-2018-00653
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2018

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 00111914001
• Device Lot Number: 85054569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 86 YR