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

Catalog Number	00515048201
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the unit would not work at all.Therefore, the nurse opened the backup of the same product and replaced the battery pack of this complaint product to new one on trial.Then, this complaint product became to work.During product evaluation and visual inspection, it was found that inside the pack had electrolyte leaked.There was no patient/harm injury reported.There was a surgical delay of about 0-15 minutes due to the preparation of a backup product.Due diligence is complete; no further information is available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).G2: foreign - event occurred in japan.Visual inspection found the outer pack was warped and the interior had electrolyte leaked inside the pack.The batteries were in the correct orientation and there did not appear to be any damage to the wiring.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Root cause has been identified as a manufacturing/design issue.The reported event was 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.

• 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: 24626516
• Report Number: 0001526350-2026-00289
• Device Sequence Number: 8689206
• Product Code: FQH
• UDI-Device Identifier: 00889024375192
• UDI-Public: (01)00889024375192(17)270829(10)79208541
• 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): 03/18/2026

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: 00515048201
• Device Lot Number: 79208541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• 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: 03/10/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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