Catalog Number 136536310 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
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Event Date 09/30/2016 |
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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Dor: on (b)(6) 2016: patient received a left hip revision to treat pain, instability, walking difficulty, squeaking secondary to liner fracture and disassociation.Upon entering the joint effusion, scar tissue, and acetabular metallic debris/metallosis was excised.The liner was worn, fractured, and disassociated from the cup.There was minimal metal wear on the rim of the cup that was cleaned, and the cup was retained.There was some wear on the explanted head due to metal-on-metal articulation of the head and rim of the cup.The stem was well-fixed and retained.The patient received a ceramic head and polyethylene liner.The procedure was completed without complications.
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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.Per internal procedures, the event information was reviewed.Medical records were received and reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).Based on the inability to find any additional related reports against the provided product code/lot code combination(s) it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Investigational inputs were requested as indicated per internal procedures for this failure mode, medical records were provided to depuy.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, 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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