Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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The article entitled, "influence of the type of hip-component fixation and age of patients on mid-term revision rate of total hip replacement" written by v.Kubinec published by acta chir orthop traumatol cech.85, 2018 was reviewed.The article's purpose was to compare different brands and different brand platforms of stems and cups to compare survival rate with specific focus on analyzing the impact of implant type and component fixation technique (cemented vs.Uncemented) correlated with patient age.It is noted that multiple depuy products are listed among non-depuy products.The article reports that all implants within the study required revision for loosening for either or both the femoral stem or acetabular cup.The cement manufacturer is not identified for the cemented implants.The article provides no information regarding reported patient experience.The article does not discuss bearing surfaces of if screws were utilized and focuses on loose cups and loose stems for survivorship.Figure 1 and 2 provide photographic illustration of the different femoral stems (cemented vs non cemented).Figure 3 provides radiographic imaging for a (b)(6) year old female patient with cemented charnley stem that loosed 3 years post implantation followed by a periprosthetic fracture.The other radiographic figures portray non-depuy products as described in figure narrative description.Depuy products: ultima cemented stem, charnley monoblock/modular cemented stem, mecroblock mr uncemented stem, aml uncemented stem, ultima threaded cups (uncemented), duraloc cup (uncemented), ultima uhmwpe cup (cemented all poly) elite plus cups (cemented all poly).Adverse events: loose stems (treated by revision).Loose cups (treated by revision).Figure 3 cemented loose charnley stem for 64 year old female (treated by revision).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.
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Search Alerts/Recalls
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