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

Catalog Number	00515048201
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device did not function prior to surgery due to battery leakage.The issue was discovered before the procedure, and no delay was reported.There was no patient involvement.Diligence is complete.
Additional Manufacturer Narrative
This event is being recorded under (b)(4).G2: foreign - event occurred in japan.E1: telephone- (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• 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: 25374614
• Report Number: 0001526350-2026-00632
• Device Sequence Number: 15818217
• Product Code: FQH
• UDI-Device Identifier: 00889024375192
• UDI-Public: 00889024375192
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 79272712
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown