The literature article entitled, "failure rates of asian-type anatomic medullary locking stemmed metal-on-metal total hip replacement: a cause for adverse tissue reactions to metal debris (armd)" written by masaru nakamura, tateaki shimakawa, shunji nakano, takashi chikawa, shinji yoshioka, masahiro kashima, shunichi toki, hidehisa horiguchi, and koichi sairyo published by journal of orthopaedic science 21 (2016) 779e785 published only 28 august 2016 was reviewed for mdr reportability.The purpose of the article: " to examine the incident rate of armd, and the implant survival rate as well as to compare the armd group and non-armd group." the article reports on 23 individual cases that received initial depuy product mom thrs between february 2007 and november 2009 of which 14 required revision due to reported pain suspected armd and 9 who did not receive revision but treated conservatively for unexplained hip pain and/or swelling.The non-revision cases had no particular findings, and symptoms subsided by conservative treatment of nonsteroidal anti-inflammatory drugs and anti-allergic agents.Each case is captured individually within linked complaints.All cases received aml-a plus stem, ultamet metal insert, ultamet head and pinnacle cup.All patients who received revision had bacterial culture inspections that were negative for infections but all were diagnosed with armd with note of debris including 13 of the 14 with deposition of metal debris at the head-neck junction.This complaint captures revision case 10 of a (b)(6) year old female with a l thr.The mri detected a type ii pseudotumor.She reported pain without note of lower extremity swelling 28 months post initial implantation and noted light brown joint fluid color intraoperatively.Deposition of metal debris at the head-neck junction was noted as positive.Revision surgery changed bearing surfaces to mop.
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Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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