ASCENSION ORTHOPEDICS, INC. UNKN PIP IMPL; HGH DMND, RVSN, S-CNSTRND, PYRLYTC CRBN, UNCMNTD FNGR PRST
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Joint Dislocation (2374)
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Event Date 05/01/2009 |
Event Type
Injury
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Manufacturer Narrative
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Literature citation: chung kc, ram an, shauver mj.Outcomes of pyrolytic carbon arthroplasty for the proximal interphalangeal joint.Plast reconstr surg.2009 may;123(5):1521-1532.Doi: 10.1097/prs.0b013e3181a2059b.Pmid: 19407625; pmcid: pmc4414247.Initial/final mdr.Internal reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
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Event Description
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It was reported that on literature review "outcomes of pyrolytic carbon arthroplasty for the proximal interphalangeal joint", 1 (one) patient suffered from a dislocation 13 (thirteen) days after having a pip joint arthroplasty with pyrocarbon implant in the right index finger.The joint was reduced and stabilized with 6 (six) to 8 (eight) weeks of external fixation and the ligamentous support was tightened sufficiently to avoid problems with dislocation.The outcome of the patient is unknown.No further information is available.
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