Model Number 1365-36-720 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)
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Event Date 07/06/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient said that they were experiencing hip pain after their surgery.The surgeon had tried to correct their leg length since they were short before surgery.He believes restoring the leg length was causing pain through soft tissue stretching.He decided to remove implants and make a shorter neck cut and sink a smaller stem.Trialing with the smaller stem the hip was unstable with the neutral ceramic liner.He removed the ceramic liner and cup and implanted a new cup and +4 10degree poly liner.He trialed again for stability.He implanted new stem and trialed again for the appropriate size head for stability.Doi: (b)(6) 2022, dor: (b)(6) 2022, affected side: right hip.
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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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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 manufacturing or material 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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