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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery the product didn't work from the time of opening.When product was dismantled, there was liquid leakage from the battery.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).Review of the device history record for 00515048201, lot number 63394463, identified no relevant deviations or anomalies.Product examination found that the product would not function.Inside the battery pack, one of the batteries was found to have leaked.The inside of the battery pack was partially corroded.This complaint is confirmed.A review using the p/n of this complaint and also based upon open and closed complaints and the keyword search using the character string ¿work¿ resulted in 75 complaints.A review using the criteria of p/n and complaint category of this complaint and also based upon open and closed complaints and the keyword search using the character string ¿work¿ and sorted by manufacturer date was performed.This review resulted in the highest occurrence for a given manufacture date was 4.The root cause of the reported event was that one of the batteries had leaked.However, the root cause for the battery leak could not be specifically determined with the provided information.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6789703
• MDR Text Key: 82779082
• Report Number: 0001526350-2017-00497
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: 63394463
• Other Device ID Number: (01)00889024375192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1