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

Catalog Number 00515048201

Device Problems Corroded (1131); Expulsion (2933)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Customer has indicated that 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 some liquid leaked from the battery.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for (b)(4), could not be performed as a lot number was not provided for the reported event.On 14 may 2019, it was reported from midorii orthopaedics that some liquid leaked from the battery of this product.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.Photos of the device were provided by the account, however.The photos indicate that the a device had corrosion inside of the battery pack.These photos confirm the reported event.While the photos provided by the account confirmed that the (b)(4) had corrosion in the battery compartment, 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.

• 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: 8625730
• MDR Text Key: 145633771
• Report Number: 0001526350-2019-00382
• 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: 05/22/2019

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 Catalogue Number: 00515048201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1