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

Lot Number 86884636

Device Problems Defective Component (2292); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Foreign - (b)(6).The investigation is still in progress.Once the investigation is complete, a follow up mdr will be submitted.

Event Description

It was reported that the cement was very tacky stuck to the nurses gloves.Surgeon didn't like the consistency so tossed and opened a new cement.Same tacky texture, tried to use it anyway.Added cement to the femoral component/patella tried to implant but cement had already cured.Spoiled patella/femoral component.No adverse events were reported as a result of this malfunction.

Event Description

No additional information available.

Manufacturer Narrative

This follow up report is being submitted to report additional information.Zimmer biomet receiving inspection record is not available for the complaint item number palacos bone cement 66022663, lot number 86884636.This item/lot number combination has not been received by or sold by zimmer biomet surgical.Reference diligence log dl765134 for objective evidence.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 was not conducted as this product was not returned by the customer.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.Investigation complete by alliance.

Event Description

No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Zimmer biomet receiving inspection record is not available for the complaint item number palacos bone cement 66022663, lot number 86884636.This item/lot number combination has not been received by or sold by zimmer biomet surgical.Reference diligence log dl765134 for objective evidence.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 was not conducted as the complaint product was returned to zimmer biomet warsaw, then subsequently discarded.Reference dl839407.As noted in dl840883, per management the femoral component listed on the complaint is not applicable as there was no alleged deficiency against the femoral component.The component was only removed due to the bone cement malfunctioning which caused the implant to no longer be viable.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.As zimmer biomet does not hold investigation responsibility for the reported product a complaint history search will not be performed.

• Brand Name: PALACOS RG 1X40 SINGLE
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7923152
• MDR Text Key: 122468687
• Report Number: 0001526350-2018-00906
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K142157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

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: 04/30/2021
• Device Lot Number: 86884636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 10/17/2018; 01/23/2019
• Supplement Dates FDA Received: 11/16/2018; 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1