This event has been recorded under zimmer biomet complaint number (b)(4).Udi# (b)(4).The following section has been updated: b5,d4,g4,g7,h2,h3, h4, h6, h10 the device history record (dhr) for 00515048200 lot number 29370093, 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) 2019, it was reported from (b)(6) that the customer reported that before using the product the operators noticed that the battery housing has increased in volume with leak of the content in the packaging.On 25 march 2019, a returned product investigation was performed on the 00515048200.The physical evaluation revealed that the battery had ruptured inside of the packaging.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515048200 batteries had ruptured inside of device 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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