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 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

(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 the surgery, this product didn't work at all since it was opened.Therefore, the surgeon used an alternative same product to complete the surgery.The device was dismantled it for investigation.Then, we confirmed that some liquid leaked from the 1 of 8 batteries.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).The device history record (dhr) for 00515048201 lot number 64087318, 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.Based on the complaint history review generating 3 complaints, the product sales of 527,685 units over the 1 october 2017 through 31 october 2018 time frame, the calculated p1 value is equal to 0.0005685%.Per zpc 12.935, 0.0001%

• 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: 8086966
• MDR Text Key: 128204916
• Report Number: 0001526350-2018-01046
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 00515048201
• Device Lot Number: 64087318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1