DEPUY ORTHOPAEDICS, INC. 1818910 PINN LNR CON +4 NEUT 28IDX50OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
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Catalog Number 121828650 |
Device Problems
Fracture (1260); Difficult to Insert (1316); Naturally Worn (2988)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (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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It was reported that the polyethylene liner was damaged during relocation of the operative hip.The liner was determined to be unusable and was removed and replaced with a new implant.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: r2561.Device history batch: null.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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).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. added: (device codes).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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Search Alerts/Recalls
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