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Catalog Number 04.027.051S |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Failure of Implant (1924); Perforation (2001); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional device product code is hwc.(b)(4).(b)(6).The subject device is not expected to be returned to the synthes manufacturer for evaluation.510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the reported subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: jun 10, 2016.Expiration date: jun 1, 2026.The review showed that there were no issues during the manufacture of the product lot that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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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Event Description
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Synthes europe reported an event in (b)(6) as follows: it was reported that revision surgery with hardware removal was performed on (b)(6) 2017 due to blade migration and perforation of the femoral head.The patient was initially implanted with a proximal femoral nail antirotation ii (pfna-ii) system on (b)(6) 2016 to treat a trochanteric femoral fracture.On (b)(6) 2017, it was discovered that the pfna-ii blade had migrated and perforated the femoral head.On (b)(6) 2017, revision surgery was performed to reset the blade to the correct position.Please see related complaint, (b)(4), which addresses and reports the first revision surgery.During the second revision surgery on (b)(6) 2017, the blade was removed completely.Concomitant medical products: pfna-ii - prox.Fem.Nail (part# 472.105s lot# unknown / quantity 1); locking bolt ø 4.9mm, self-tapp (part# 459.340vs / lot# unknown / quantity 1); pfna-ii end cap (part# 473.170s / lot# unknown / quantity 1).This report is 1 of 1 for (b)(4).
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Search Alerts/Recalls
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