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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

This complaint is being reported by zimmer biomet as (b)(4).The product will not be returning to the manufacturer for evaluation; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It is reported that while using a mold on a femur for a tkr to make room for the new implants, the knee was put in extension breaking the cement.There was no harm or any additional complication that was reported.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This complaint was recorded by zimmer biomet in (b)(4).This follow-up report is being submitted 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.

• Brand Name: UNKNOWN PALACOS BONE CEMENT
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7445735
• MDR Text Key: 106321278
• Report Number: 0001526350-2018-00325
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: PK142157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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: 04/19/2018
• 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: UNK 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