HIP KIT
Received Jul 29, 2026 · Event occurred Dec 25, 2025
Report 0001526350-2026-00909 · MDR key 50067636
Device
Product problems
- Failure to Power Up
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that during surgery on (B)(6) 2025, the unit was not working and was suspected to be due to battery power failure, as there was no power to turn on. There was no patient impact or delay. During the investigation, a visual inspection of the interior of the pack found electrolyte leakage inside the pack. Due diligence is complete and there is no additional information available.
Additional Manufacturer Narrative
This complaint is recorded by Zimmer Biomet under CMP-1026609. G2: Foreign - Event occurred in ChinaThe device was returned with the batteries removed from the pack. Functional testing of the returned product found the device 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 electrolyte leaked inside of the pack. There did not appear to be damage to the wiring of the pack.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause is attributed to a manufacturing issue exacerbated by a design issue.The 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.