STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.
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Event Description
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As reported: "i had a problem with the extension of the prosthesis pin (b)(4) (left distal femoral jts).It started with the regular sound of gear movement but after 30s changed to a humming sound.I fallowed the trouble shooting protocol but it did not help.We tried repositioning the leg, turning to b that gave gear movement sound and then it worked for several seconds and again started humming, we let her walk." update (b)(6)2021 wg: additional information received from distributor: i had another extension.And there the prosthesis extended the 4mm we intended, so, i do not think the problem is with the unit.
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