This product is manufactured by zimmer biomet (b)(6) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(6) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Complaint investigation: 1.Event description: it was reported that the patient underwent initial surgery in 2011 and then underwent first revision surgery on (b)(6), 2014 whereby the revitan stem was implanted.The patient underwent subsequent revision surgery on an unknown date after sustaining an implant fracture on (b)(6) 2021.Harm: s3 - non-functioning joint.Hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: - no medical data relevant to the case has been received.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.3.Devices analysis: - no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as only the complained product is known.- dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that the patient underwent initial surgery in 2011 and then underwent first revision surgery on (b)(6), 2014 whereby the revitan stem was implanted.The patient underwent subsequent revision surgery on an unknown date after sustaining an implant fracture on (b)(6), 2021.The quality records (device history records, raw material certificate) show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Neither x-rays, operative notes, office visit notes, nor devices or photos of the devices were received; therefore the condition of the components is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, bmi, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.No product id of any of the further involved devices has been provided.It is not known if the subsequent revision surgery has already been performed or on what date it has been planned for.Based on the investigation the reported event cannot be confirmed.Based on the limited provided information and the results of the investigation, we were not able to identify a specific root cause for this issue.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.
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