It was discovered that the legal manufacturer of the reported product is zimmer (b)(4), (b)(4).The initial report was submitted under mfr report number 0001822565-2016-04508 by zimmer inc., (b)(4).All available information is covered in the report at hand.A technical investigation was not possible to perform, as the devices were not at hand for investigation.An e-mail requesting missing device data information was sent on (b)(6) 2016 to the author of the article.An e-mail was received in response from the author, carsten perka (md), on (b)(6) 2017.He wrote that he was unable to answer our questions as the evaluation happened 18 years ago.However, based on the available information the investigation is conducted with outcome as follows.Device history records (dhr) review results as no lot numbers were provided for the devices, the device history records could not be reviewed.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Trend analysis a trend analysis could not be performed as no item number was available.Event summary: it was reported that significant lateral migration (> 3mm) occurred in (2) patients.Significant medial migration occurred in (1) patient (6.7mm).Significant caudad migration occurred in (2) cases, one of which was due to septic loosening and the other due to pelvic ring fracture.Cranial migration >3mm occurred in (12) patients, (9) had migration (> 4mm) and (4) had migration > 5mm.Clinical review of received journal/article: the received journal/article was thoroughly reviewed and can summarized as followed: considering the involved patient population and the results of the study, zimmer biomet can support the author¿s conclusion on this study.For the time being, the provided patient benefit clearly exceeds the potential patient risks and therefore usage of the burch-schneider cage is fully justified for patients where implants that allow bone integration cannot be implanted.Devices analysis a device analysis could not be performed as no product was returned to zimmer biomet for in-depth analysis.Root cause determination using dfmea: aseptic loosening, migration of implant due to insufficient secondary stability due to surface structure.Not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance.Impingement with stem (decreased rom), dislocation, subluxation,migration of implant,stress shielding due to malpositioning of the implant, wrong alignment.Possible, as no x-rays were provided.Migratin of implant due to wrong selection of component sizes, planning, operation technique and use of instruments.Possible as no x-rays were provided.Conclusion summary neither x-rays, operative notes, nor office visit notes were received for a deep assessment.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), relevant medical history and adherence to rehabilitation protocol are unknown.Due to significant lack of information, it is not possible to confirm one specific root cause for the event report.Based on the available information, we consider the following as most probable root cause: patient disregards limits of the device/wrong behavior oft he patient/high patient acitvity, as these factors are out of zb control.However, based on the information available for the investigation, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).
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It was reported in a journal article, that patients were implanted with b-s reinforcement cage hip implants on an unknown date.Significant lateral migration (> 3mm) occurred in (2) patients.Significant medial migration occurred in (1) patient (6.7mm).Significant caudal migration occurred in (2) cases, one of which was due to septic loosening and the other due to pelvic ring fracture.Cranial migration >3mm occurred in (12) patients, (9) had migration (> 4mm) and (4) had migration > 5mm.(perka, carsten and ludwig, ralph: reconstruction of segmental defect during revision procedures of the acetabulum with the burch-schneider anti-protrusio cage, in: the journal of arthroplasty (2001) vol.15 no.5.).
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