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

Catalog Number	00515048200
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).G2: foreign - event occurred in china visual examination of the returned product identified the device was returned with the batteries removed from the pack.Therefore, a lab battery was used for testing.Visual inspection of the interior of the pack found the batteries had leaked electrolyte inside of the pack.During functional testing the device would not power on.Visual inspection of the interior of the handpiece found the plunger was stuck in place inside the plunger housing.Also, the motor would power on when the electrodes were made to touch in both trigger modes when connected to the lab battery pack.No other damage was found.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to device manufacturing process.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during surgery, the unit would not work properly as no water came out from the device.There was a surgical delay of 20 minutes for awaiting a new device.There was no patient harm/injury reported.The surgical technique for the product was utilized.The saline bag was located above the patient.The unit was operated with a continuous trigger operation for 30 seconds.During the investigation, it was found that the batteries had leaked electrolyte inside the pack.Due diligence is complete; no further information is available.

• Brand Name: HIP KIT
• Common Device Name: 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24689022
• Report Number: 0001526350-2026-00318
• Device Sequence Number: 9706078
• Product Code: FQH
• UDI-Device Identifier: 00889024375185
• UDI-Public: (01)00889024375185(17)280206(10)80941726
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00515048200
• Device Lot Number: 80941726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown