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

Catalog Number 00515048201

Device Problem Expulsion (2933)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

This device failure is recorded by zimmer biomet under (b)(4).(b)(4).Foreign: (b)(6).The product is in the process of returning for evaluation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that during the surgery, it was found that the battery pack of this product has already exploded when the outer box of this product was opened.Therefore, the nurse prepared an alternative same product to complete the surgery.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 lot number z000010702, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2018, it was reported from (b)(6) hospital artificial joint center that the battery pack of this product had ruptured inside the packaging.On 05 december 2018, a returned product investigation was performed on the 00515048201.The physical evaluation revealed that the device batteries had ruptured inside the packaging.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515048201 battery pack had ruptured inside the packaging, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.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 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: 7915323
• MDR Text Key: 122048018
• Report Number: 0001526350-2018-00903
• 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: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 00515048201
• Device Lot Number: Z000010702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1