Model Number 1217-31-046 |
Device Problems
Device Dislodged or Dislocated (2923); Osseointegration Problem (3003); Noise, Audible (3273)
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Patient Problems
Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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(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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Compass case (b)(4) reports: it was reported that the patient presented with a squeaking hip and underwent revision surgery.The poly was found to be worn, and was dissociated from the cup.The surgeon says it ¿spun out¿.It was also indicated that there was loosening of the cup at the bone to implant interface.Doi: (b)(6) 2016, dor: (b)(6) 2021, affected side: unknown hip.
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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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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