Literature article received entitled "is increased modularity associated with increased fretting and corrosion damage in metal-on-metal total hip arthroplasty devices?".Literature article entitled, ¿is increased modularity associated with increased fretting and corrosion damage in metal-on-metal total hip arthroplasty devices? a retrieval study ¿by genymphas b higgs, ms, et al, published by the journal of arthroplasty (2013), vol, 28, supplement 1, pp.2-6 was reviewed for mdr reportability.This retrieval study documents taper damage at modular interfaces in retrieved mom tha systems and investigates if increased modularity is associated with increased fretting and corrosion.One hundred thirty-four (134) heads and 60 stems (41 modular necks) of 8 different bearing designs (5 manufacturers) were analyzed.The retrieved devices were manufactured by 5 different companies: zimmer, warsaw, indiana (n = 84/137, 61%); biomet, warsaw, indiana (n = 28/137, 20%); depuy, warsaw, indiana (n = 20/137, 15%); wright medical technology, arlington, tennessee (n = 4/137, 2.9%); smith and nephew, memphis, tennessee (n = 1/137, 0.7%).For this study, 134 heads, 60 stems (41 modular necks), 18 modular acetabular liners and 11 corresponding acetabular shells were analyzed.All interfacing components in this study were of the same manufacturer.Device information (inclusive of manufacturer, design, size, and constituent material) was obtained from component markings, patient records, or directly from the manufacturer.Damage at the shell¿liner interface of 18 modular cocr acetabular liners and the corresponding 11 acetabular shells was also evaluated.The results of this study support the hypothesis that fretting, and corrosion damage occurs at a variety of modular component interfaces in contemporary mom thas.We also found that modularity of the femoral stem was associated with increased damage at the head.An analysis of component and patient variables revealed that dissimilar alloy pairing, larger head sizes, increased medio-lateral offsets and longer neck moment arms were all associated with increased taper damage at the modular interfaces.The majority of components were revised for loosening (n = 98/137, 72%), infection (n = 12/137, 8.8%), adverse local tissue reaction (n = 7/137, 5.1%), and instability (n = 6/137, 4.4%; table 1).Intraoperative evidence of adverse local tissue reaction (altr) was identified in the operative reports of 33/137 (24%) cases.Altr was not explicitly stated in all 33 cases, but was identified if ¿masses¿, ¿cysts¿, ¿enlarged bursae¿, ¿pseudotumor¿, ¿hypersensitivity¿, and/or ¿lymphocytic infiltration¿ (aseptic) were discussed in the operative reports.Evidence of taper damage was found on all types of modular interfaces examined in this study.Mild to severe damage (score = 2) was observed on 128 of 134 (96%) head tapers, 54 of 60 (90%) stem tapers, all 41 (100%) distal tapers of modular necks, 17 of 18 (94%) cocr acetabular liners, and all 11 modular acetabular shells.Mild to moderate damage, apparent as circular fretting patterns, was noted on the mating surface of all modular shells.Scores on the mating surface of modular shells were correlated with those of the modular liners.There was corrosion and damage on the inside of the femoral heads, as well.The authors do not differentiate the devices with specific patient harms within the text of this article, but they do confirm that wear and corrosion were seen on cups, heads, liners, and stems.
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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 number was not provided.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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