MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Excessive Heating (4030)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Report source: foreign - (b)(6).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that during surgery the rinse solution has been renewed and it has been noticed that the housing is getting hot.Also, liquid is leaking from the battery box.4 batteries were deformed and fused.There was no harm or injury to the patient.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow up report is being submitted to report additional information.The device history record (dhr) for 00515048201, could not be performed as a lot number was not provided for the reported event.On (b)(6) 2018, it was reported from (b)(6) that the pulsavac plus battery tray is running out.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.The reported event can, therefore, not be confirmed.The root cause of the reported event cannot be specifically determined with the provided information because the product was not returned for evaluation.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 information was received.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7934391
• MDR Text Key: 122813396
• Report Number: 0001526350-2018-00921
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00515048201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1