This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) 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 yet, however it is indicated by complainant that it will be returned 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).Product not available.
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This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that the patient was implanted with a total hip replacement, consisting of a continuum cup, constraint liner, cls stem and a cocr head on (b)(6) 2021.Subsequently, the patient underwent revision surgery on (b)(6) 2021 due to dislocation of the head.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-ray: one radiograph was provided and reviewed by a health care professional.Review of the available image identified a left hip arthroplasty with superior dislocation of the prosthetic femoral head without fracture or evidence of implant loosening.The left hip acetabular cup abduction angle measures approximately 50 degrees.Product evaluation: the cocr head was not returned; therefore, visual evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the reported head/liner combination was reviewed for compatibility with no issues noted.However as the stem and shell used are unknown, it is unknown if the entire construct is compatible.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient was implanted with a total hip replacement, consisting of a continuum cup, constraint liner, cls stem and a cocr head on may 25, 2021.Subsequently, the patient underwent revision surgery on sep 06, 2021 due to dislocation of the head.The quality records 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).The cocr head was not returned.However, based on the radiograph obtained, the dislocation can be confirmed.However, a specific cause for the dislocation could not be determined.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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