This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: event problem: battery explosion.Device history record (dhr) for z000011159 lot number 00515048201, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2018, it was reported from (b)(6) hospital that the battery has already exploded since it was opened.On 18 february 2019, a returned product investigation was performed on the 00515048201.The physical evaluation revealed that the battery had ruptured inside the packaging.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515048201 battery had ruptured inside of the packaging, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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