Catalog Number UNK SHOULDER METAGLENE |
Device Problems
Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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It has been reported that a female patient age 76yrs who had a left reverse shoulder replacement (delta xtend) in 2018 has presented with a displaced glenosphere.The metaglene baseplate is still in situ but the glenosphere has tilted inferiorly leaving a 45 degree superior gap.The patient reported to him that she pushed herself up in bed with her arm and heard a crack.It appears from the xray that the glenosphere may be locked around the base of the metaglene.Please see attached xray images.Doi: 2018.Dor: unknown.Affected side: left shoulder.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos confirmed the reported allegation.The observed position of the glenosphere denotes an implant disassociation most likely caused by a fracture of the glenosphere central screw.It is not unreasonable to conclude that audible sound was present due to the unintended interaction between both devices during movement.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number or product code was provided for this device.
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Search Alerts/Recalls
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