MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PALACOS RG 1X40 SINGLE; PALACOS R+G 1X 40G SINGLE (WITH GENTAMICIN)

Catalog Number 00111314001

Device Problem Sticking (1597)

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 palacos cement was claimed defected, and the staff said that it was too sticky to use.The batch was mixed separately, at 45 seconds and the room was cold.There was no known adverse event that was reported.

Manufacturer Narrative

This event was recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Udi #: (b)(4).Investigation summary: review of the receiving inspection report for catalog number 00111314001, lot number 84584568, identified no relevant deviations or anomalies.Review of the receiving inspection report for catalog number 00111314001, lot number 84904569, identified no relevant deviations or anomalies.Heraeus batch records 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, the root cause of the reported event is "presumably a result of incorrect preparation due to professionals" with a potential explanation as "inadequate waiting time/mixing." the investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Complaint history review: as zimmer biomet does not hold investigation responsibility for the reported product, a complaint history search will not be performed.

Event Description

It was reported that 3 batches of palacos cement were claimed defected.Staff saying too sticky to use.All three batches were mixed separately each at 45 seconds.Room was very cold.Also two batches of depuy cement had same problem.04/10/2017: per (b)(6), the reported issue occurred during surgery.It was reported that there was no alternate device was retrieved and there was a surgical delay for 20mins.The event was not identified immediately upon opening the device and before first use.The event not occurred during first-ever use of the product and also not related to surgical technique or user error.No medical intervention/additional surgical procedure was required and the surgical technique for the product was utilized.The udi number of the product is not known.Review of information entered in this etq file determined that the reported issue occurred on (b)(6) 2017.It was reported that there was no patient harm/injury associated with the report.No further clinical information is indicated and request sent for product return information./(b)(6) 04/13/2017: per (b)(6), the product was used and could not be returned for investigation.No further follow up information is indicated.

• Brand Name: PALACOS RG 1X40 SINGLE
• Type of Device: PALACOS R+G 1X 40G SINGLE (WITH GENTAMICIN)
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 6440176
• MDR Text Key: 71284877
• Report Number: 0001526350-2017-00138
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: PK030902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 00111314001
• Device Lot Number: 84585468
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2018
• Removal/Correction Number: N/A
• Patient Sequence Number: 1