Model Number 1521-90-051 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Discomfort (2330); Physical Asymmetry (4573)
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Event Date 09/02/2022 |
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) 2011, the patient underwent the surgery via tha for right hip with implants in question.The surgery was completed successfully without any surgical delay.After the surgery, the patient consulted a doctor on (b)(6) 2022, about symptoms such as right hip discomfort and right knee collapse.A revision surgery was performed on (b)(6) 2022.Extractors by zimmer biomet were used to remove the cup, resulting in minimal bone loss.The cup was replaced to g7 produced by zimmer biomet, the hooded liner increased the head diameter to 36 mm, the head was extended to +3 mm, and the stem that was implanted on (b)(6) 2011, has been left.No defect such as tranionosis was seen in the removed implants, and the poly liner was slightly worn only.The patient has been paralyzed as a sequela of infantile paralysis on the left side and conducts activities of daily living with weight applied only to the right side.There is a considerable difference in leg length between left and right.No further information is available.
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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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