MAUDE Adverse Event Report: Zimmer Surgical, Inc. HIP KIT; Lavage, Jet

Catalog Number	00515048200
Medical Device Problem Codes	Inability to Irrigate (1337); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the device was not spraying and the battery was overheating.There was no patient impact or delay.During product evaluation it was found that the device leaked electrolyte.Due diligence is complete and there is no additional information available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Functional evaluation of the returned product found the device did power on and function normally in both modes when connected to a lab battery pack.Visual evaluation found electrolyte had leaked inside of the pack, additionally, there did not appear to be damage to the wiring of the pack.No other damage was found.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause is attributed to a manufacturing issue exacerbated by a design issue.The reported 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.E1 telephone number: (b)(6).G2 country: china.

• 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 ; +1(574)526-0384
• MDR Report Key: 50485193
• Report Number: 0001526350-2026-01049
• Device Sequence Number: 21390869
• Product Code: FQH
• UDI-Device Identifier: 00889024375185
• UDI-Public: (01)00889024375185(17)261009(10)73095426
• 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): 08/27/2026

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: 00515048200
• Device Lot Number: 73095426
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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