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

Catalog Number	00515048200
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the pulsavac won't turn on/respond.Investigation results found the batteries had leaked electrolyte inside of the pack.There was no patient harm.There was no medical intervention.There was no surgical delay.Due diligence is complete, there is no additional information available,.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4) g2: foreign - event occurred in thailand.Functional testing of the returned product found the device would not power on with the original battery pack but did power on and function normally in both modes when connected to a lab battery pack.Visual inspection of the interior of the pack found the batteries had leaked electrolyte inside of the pack.There did not appear to be damage to the wiring of the pack.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as a manufacturing issue exacerbated by a design issue.Able to confirm reported event.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 ; +1(574)526-0384
• MDR Report Key: 50371267
• Report Number: 0001526350-2026-01016
• Device Sequence Number: 15907164
• Product Code: FQH
• UDI-Device Identifier: 00889024375185
• UDI-Public: (01)00889024375185(17)271115(10)79798865
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 08/21/2026

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: 79798865
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2026
• 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: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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