It was reported by the (b)(6) register (lroi) that a number of patients underwent revision surgery due to loosening, dislocation, infection, wear, peri-prosthetic fracture, girdlestone situation, peri-articular ossification and other reasons.
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This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported by the dutch register (lroi) that a number of patients underwent revision surgery due to loosening, dislocation, infection, wear, peri-prosthetic fracture, girdlestone situation, peri-articular ossification and other reasons.Review of received data: due diligence: no further information available, as affected hospitals are no known.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Dhr review: the dhr check could not be performed as the lot number was not available.Ie/capa/hhe(d) search: data analysis performed in response to the request from lroi did not identify any issues requiring further action and concluded that the data supports the continued use of respective systems.The overall residual risk of the devices is considered acceptable according to the risk management files.The post market surveillance reviews do not indicate any requirement for further action based on the existing clinical data.In summary, no further action is required at this time.Ongoing monitoring of the products in scope will continue to be performed in accordance with monthly complaint trending and post market surveillance.Conclusion: it was reported by the dutch register (lroi) that a number of patients underwent revision surgery due to loosening, dislocation, infection, wear, peri-prosthetic fracture, girdlestone situation, peri-articular ossification and other reasons.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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