MAUDE Adverse Event Report: ZIMMER SURGICAL ZIMMER POWER-MIX VACUUM CEMENT MIXING SYSTEM

Catalog Number 00-5049-025-01

Device Problems Fracture (1260); Component Missing (2306)

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

Event Date 03/19/2014

Event Type  malfunction  

Event Description

It was reported that the zimmer power-mix vacuum cement missing system flange of the cartridge had been fractured during injecting the bone cement into femoral canal.The surgery was finished with another zimmer power-mix and bone cement.The broken pieces had not fallen into the patient, and additional procedure time was attributed to preparation for another bone cement.

Manufacturer Narrative

No lot number information was provided, so a release to inventory date could not be determined.There was no review of the quality records because a lot number to identify the product was not given.The complaint about the broken flange was confirmed.It appeared as though the bone cement hardened during the procedure.Once the cement hardened, then the cement would not flow through the shaft.If continued force on the cartridge by the cement gun that was used, then the flange would break.Because no times were given about how long the cement was in the cartridge and no lot numbers on the cartridge or bone cement were provided, a direct cause cannot be determined; however, the cause is most likely due to human error in that the cement was already hardened and broke the flange.

• Brand Name: ZIMMER POWER-MIX VACUUM CEMENT MIXING SYSTEM
• Type of Device: ZIMMER POWER-MIX VACUUM CEMENT MIXING
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 3973052
• MDR Text Key: 4608675
• Report Number: 1526350-2014-00337
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-5049-025-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1