MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PALACOS CEMENT; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was initially reported that the cement was broken at anterior chamber, anterior resection intersection.It was the 2nd or 3rd that had broken at that point.Mold was used & cemented on femur.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Investigation summary: since the complaint product item number and lot number are both unknown, zimmer biomet receiving inspection record and heraeus device history record reviews cannot be performed.Also, the manufacturing and expiration dates are unknown based on the complaint product item number and lot number both being unknown.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 "misalignment/wrong application time." 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.

• Brand Name: PALACOS CEMENT
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7469952
• MDR Text Key: 106963428
• Report Number: 0001526350-2018-00373
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: PUNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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: UNKNOWN PALACOS CEMENT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 54 YR