Model Number 1217-22-052 |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 12/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b(4).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 was reported that post operative insert breakage.The patient accepted tha on (b)(6) 2018.No anomaly was observed during procedure.After 5 months patient felt pain and returned back hospital.It was noted that insert broke and implant loosened on (b)(6) 2018.The revision surgery will be operated.Now patient condition is stable.
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Manufacturer Narrative
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(b)(4).No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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