ASCENSION ORTHOPEDICS, INC. PIP IMPLANT; HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Deformity/ Disfigurement (2360)
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Event Date 12/05/2011 |
Event Type
Injury
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Event Description
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It was reported that on literature review ¿pyrocarbon proximal interphalangeal joint arthroplasty: outcomes of a cohort study ", three (3) joints had developed boutonniere deformity after a proximal interphalangeal (pip) joint arthroplasty procedure using a pyrolytic carbon implant from smith and nephew.One patient developed the boutonniere deformity after a fall and a release was performed.The patient then developed a swan neck deformity, which later required a fds tenodesis.On the final follow-up, the range of motion was 30¿90°, and the patient was pain-free and satisfied.No further information is available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Mcguire, d.T., white, c.D., carter, s.L., & solomons, m.W.(2012).Pyrocarbon proximal interphalangeal joint arthroplasty: outcomes of a cohort study.Journal of hand surgery (european volume), 37(6), 490-496.Doi: 10.1177/1753193411434053.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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Manufacturer Narrative
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Corrected data: h6 (health effect - impact code, type of investigation).Results of investigation: the product has not been received at the aus site for evaluation and photographs were not provided, so the complaint could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified similar reported events for this product family.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Clinical/medical evaluation: patient-specific supporting documentation was not provided, so a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.The complaint alleges that revision surgery was required.As no products have been received for evaluation, it could not be determined whether the device contributed to the reported events.As the product lot numbers were not reported, it could not be determined whether the devices met manufacturing specifications.According to risk management documentation for pip implants, potential causes for the reported event include incorrect surgical technique, incorrect size or patient selection, and improper post-surgical activity.Based on this investigation, the need for corrective action is not indicated as no non-conformances or manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.
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