This report is being submitted to relay corrected data and additional information.The following sections are being reported: b4: date of this report was updated.D2: device product code was corrected.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: component code was added: 4755.H6: investigation type codes were added: 3331, 4109, 4111 and 4114.H6: investigation findings code was added: 3221.H6: investigation conclusions codes were added: 4315.H10: narrative/data was updated.The product was not returned.Therefore, the reported event could not be verified.Based on the evaluation, device malfunction could not be verified.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when the unit left zimmer biomet.Dhr review for the lot (2018120976) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.However, dhr review could not be performed for the unknown implant since the lot number was unknown.Complaint history review was performed for the lot (2018120976) for similar events and no other complaint about nonconforming products was identified.Based on the investigation, risk review and ifu, the most likely causes determined from the investigation are long term excessive loading on device assembly or parafunctional habits of the patients (e.G.Clenching, bruxism and overloading).No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
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