Litigation alleges that the patient suffers from pain, discomfort, inflammation, and difficulty ambulating.It is also alleged that the patient suffers from a squeaking noise, a metallic taste in his mouth, and dislocation.Update: 6/4/2013 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update rec'd (b)(6) 2014-he complaint has been updated because it was reported that the patient's left hip was revised on (b)(6) 2014 to address a malpositioned cup which caused accelerated wear of the metal liner.The complaint was updated on: 05/01/2014.Update (11/21/16) ¿ pfs and medical records received.After review of the medical records for mdr reportability, alleges pain, discomfort, looseness, poor range of motion, and multiple dislocations.The revising surgeon's h&p indicates 2 dislocations, squeaking sound in hip, instability, and markedly elevated cobalt chromium levels, but states "patient denies pain in the hip".Noted that left hip x-rays indicated acetabular component "is quite vertical.This is clearly the cause of his elevated cobalt chromium levels and instability." in revision op note ((b)(6) 2014), identified a large, seropurulent effusion, as well as blackened synovium around the joint.Stem is added to complaint, adverse tissue reaction: metallosis added to patient harm, and abnormal clinical results: metal ions added to harms for affected products.The complaint was updated on: 12/9/2016.
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Additional narrative: the devices associated with this report were not returned.A search of the complaint database found no additional related reports for the reported part and lot code combinations.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to determine a root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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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.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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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