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

Model Number N/A

Device Problem Device Packaging Compromised (2916)

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

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).A follow up medwatch will be submitted once the investigation is complete and a root cause has been established.

Event Description

It was reported that a pin hole was noticed through the protected layer.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.

• 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: 7409417
• MDR Text Key: 105154999
• Report Number: 0001526350-2018-00303
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• 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: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• 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: 00111314001
• Device Lot Number: 86904602
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1