Catalog Number UNK HIP FEMORAL STEM C-STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Limb Fracture (4518)
|
Event Date 07/31/2023 |
Event Type
Injury
|
Event Description
|
This complaint is from a literature source.The following literature cite has been reviewed: madanipour s, singh p, patel a, beg r, sha m, grewal is, iranpour f, subramanian p.Subsidence in centraliser sign: a novel tool to help predict early subsidence in periprosthetic femoral fractures around polished tapered stems treated with internal fixation.Cureus.2023 jul 31;15(7):e42742.Doi: 10.7759/cureus.42742.Pmid: 37654957; pmcid: pmc10467608.Objective and methods: when treating periprosthetic femoral fractures (ppf) around polished taper slip stems (pts), determining which patients can be successfully treated with internal fixation can be challenging.The authors identified the subsidence-in-centralizer (sinc) sign as a radiographic feature of ppf around pts stems.The purpose of this retrospective study is to test the hypothesis that a positive sinc sign can help predict a poorer outcome for the fixation of ppffs.Retrospective identification of all cases of periprosthetic hip fractures presenting to a single hospital system in the united kingdom between january 2011 and december 2020 was performed and 54 patients identified for the study.Of the 54 patients, three were implanted with depuy c-stem femoral stems.The remaining 51 patients received competitor implants and will be excluded from this complaint.The cement restrictor utilized is a competitor product.The authors do not provide the manufacturer of the cement utilized with the stems.This complaint will capture the results associated with the depuy c-stems.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: c-stem femoral stem.Patient specific adverse event(s) and provided interventions associated with depuy devices: 84-year-old patient sustained a ppff around the cemented left femoral stem treated successfully with orif.
|
|
Manufacturer Narrative
|
Product complaint #: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
|
|
Search Alerts/Recalls
|
|