Literature article abstract entitled, ¿validation of use of transverse acetabular ligament and mechanical angle guide device to orient the acetabular cup¿ by archit agarwal, et al; published by journal of clinical orthopaedics and trauma (2020), vol.11, pp.S766-s771, was reviewed.The purpose of this study was to verify the reliability of using the transverse acetabular ligament as an anatomical landmark to orient the cup in primary tha and to compare that to cups placed with a mechanical angle guide device in 35 patients in a three-year time period beginning in (b)(6) 2016.The patient received a corail stem and pinnacle cup.A variety of femoral heads and acetabular liners were used.The manufacturers were not specified but are assumed to be depuy products.Results: 1 reported joint dislocation.Treatment was not specified.15 cups in 45-50 degrees anteversion identified in radiographic studies.No treatment provided and no patient consequences reported.Radiographic images are available on pages s767 and s768.Captured in this complaint: 1 unk liner and 1 unk head: pec: implant dislocation.15 unk cups: pec: implant malposition.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the attached images could not confirm the reported complaint.A root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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