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

Catalog Number 00515048200

Device Problem Expulsion (2933)

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

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).Customer has not indicated that the device is being returned for evaluation, however investigation is in process.Once the investigation is complete, a supplemental report will be filed accordingly.Requested but not returned by hospital.

Event Description

The customer reports that the battery pack has heated and melted.The plastic and the batteries inside are deformed.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Device not returned for evaluation.The device history record (dhr) for 00515048200, could not be performed as a lot number was not provided for the reported event.The lot number is unknown, the manufacture and sterility dates cannot be determined.On 24 january 2019, it was reported from hopitaux (b)(6) that the customer reports that the battery pack has heated and melted.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 event information available.

• 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: 8353613
• MDR Text Key: 136865495
• Report Number: 0001526350-2019-00122
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00515048200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1