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

Catalog Number	00515048201
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being recorded under (b)(4) as an initial/final report.(b)(6).The device was tested with a lab battery pack due to a battery leak of the original battery pack.Functional testing of the returned product found the suction was not working and the motor made a high-pitched noise.Visual inspection of the interior of the original pack found the batteries leaked electrolyte inside the pack.Visual inspection of the interior of the handpiece found the motor mounts were melted and warped, and there was damage to the teeth of the face gear.Additionally, the plunger was stuck in place inside the housing.There were no signs of smoking, burning, charring, or other related damage.Review of the device history record identified no deviations or anomalies during manufacturing.The reported event is confirmed.The root cause of the reported issue is attributed to design and/or manufacturing issues.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 the surgery, this complaint product didn't work even the motor at all.No serious injury.No info on delay.During final investigation it was noted that the interior of the original pack found the batteries leaked electrolyte inside the pack diligence is complete.

• 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: 25000066
• Report Number: 0001526350-2026-00500
• Device Sequence Number: 18595325
• Product Code: FQH
• UDI-Device Identifier: 00889024375192
• UDI-Public: (01)00889024375192(17)270910(10)79181418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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
• Device Catalogue Number: 00515048201
• Device Lot Number: 79181418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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