Catalog Number 121881754 |
Device Problems
Fracture (1260); Noise, Audible (3273)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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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 was reported that on (b)(6) 2014, the patient underwent the primary surgery via tha with the liner in question.The surgery was completed successfully without any surgical delay.After the surgery, the surgeon asked our sales rep to check the x-ray images for suspected liner breakage on (b)(6) 2022.The x-ray on the left side of the attached image taken one week after the primary surgery shows that the lower part of the ceramax liner appears to be floating.Damage can be confirmed by checking the center x-ray of the attached image taken in 2016 and the right x-ray of the attached image taken in 2022.The sales rep plans to discuss these situations with the surgeon.No further information is available.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Additional information received indicated that the patient came to the outpatient clinic with symptoms of hip joint squeaking (abnormal sound from the sliding surface), but had no pain.The head and the broken liner were removed during revision surgery on (b)(6) 2023.There was no surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Visual examination of the photographic evidence of device confirmed the reported event.It was possible to observe fragments of the insert after fracture event.Based on the provided evidence, a further analysis was not able to be performed.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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