Catalog Number 121881752 |
Device Problems
Fracture (1260); Noise, Audible (3273)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/22/2023 |
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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Liner breakage post-op.More than 9 months after bilateral hip arthroplasty, the patient had left hip movement sound.The patient went to the hospital for examination, and it was found by x-ray that the ceramic liner implanted on the left side was cracked.A second surgery was required, but the timing of the second surgery is currently uncertain.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence confirm the reported allegation.The ceramic insert was found fractured into multiple fragments.Additionally, signs of metal transfer can be observed on the inner surface and on the fractured fragments, most likely caused by chafing between metal parts and the fragments of insert.Based on the observations, it reasonable to conclude that audible sound would be present.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the ceramic insert belongs to the shop order (b)(4).Protocols and acceptance certificate were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.Device history review a manufacturing record evaluation was performed for the finished device [121881752 / 3719590] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
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Event Description
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Additional information was received and stated that the patient underwent a second procedure on (b)(6) 2023.The fractured liner and worn hip femoral head were removed.Replaced with new ceramic head and acetabular liners.
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Search Alerts/Recalls
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