ASCENSION ORTHOPEDICS, INC. UNKN PIP IMPL; HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARB, UNCEMENTED FINGER PROS
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Catalog Number UNKNOWN |
Device Problems
Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Erosion (1750); Loss of Range of Motion (2032); Discomfort (2330); Joint Dislocation (2374)
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Event Date 05/01/2012 |
Event Type
Injury
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Manufacturer Narrative
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Internal reference number: (b)(4).Ono s, shauver mj, chang kwc, chung kc.Outcomes of pyrolytic carbon arthroplasty for the proximal interphalangeal joint at 44 months' mean follow-up.Plast reconstr surg.2012 may;129(5):1139-1150.Doi: 10.1097/prs.0b013e31824a2e38.Pmid: 22261566; pmcid: pmc3341519.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 at 44 months mean follow-up", ten (10) months after a pipj joint replacement surgery on one (1) patient's right index finger, the patient recognized a decreased range of motion as well as a clicking of her right index finger, although x-ray showed no evidence of the implant¿s dislocation or loosening.But, seventeen (17) months after surgery, the pyrocarbon implant of the right index finger was dislocated.Also, radiographic studies also showed the loosening of the implant.The dislocation was managed conservatively by dorsal blocking splinting.Although the range of motion of the index finger decreased, the index finger appears to be in appropriate position with no malrotation and is not causing the patient any pain.The patient was still able to perform activities of daily living and did not desire fusion of this joint.No further information is available.
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Search Alerts/Recalls
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