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

Catalog Number 00111314001

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that there was an eyelash within the cement when applying the cement into the patient for total knee arthroplasty.The staff involved in preparing all wearing ortho "hoods" which completely contain hair.The surgeon believed the hair came from the manufacturing process.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).Review of the receiving inspection report for 00111314001, lot number 82064447, identified no relevant deviations or anomalies.29 pieces were inspected, 13 accepted and 16 rejected for damage.Heraeus batch records review indicates there were no quality deviations, no change notifications, and no corrective and preventive actions.All verifications, inspections, and tests were successfully completed.Product examination was not performed as the product was not returned.This complaint is unconfirmed.Per heraeus, the root cause of the reported event is presumably insufficient cleanliness in production areas, parts contaminated with fibres, dust, allergenic-, toxic, endotoxic-, active biologic substances; potential harm : inflammation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information is available.

• 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: 8566753
• MDR Text Key: 144271659
• Report Number: 0001526350-2019-00328
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K031673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 00111314001
• Device Lot Number: 82064447
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1