Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Edema (1820); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Joint Dislocation (2374); Test Result (2695); No Code Available (3191); Swelling/ Edema (4577)
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Event Date 04/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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After review of medical records, patient was revised to address failed right total hip arthroplasty and primary degenerative osteoarthritis of the left hip.It was indicated that the patient developed elevated ion levels, some increasing pain, implant bearing wear, and pre-op mri shows fluid collection in the joint.Operative notes stated that there was some trunnionosis on the trunion taper.There was a fair amount of metallosis on the backside of the metal liner.The acetabular component was cleaned of all metallic debris.Dor: (b)(6) 2004; dor: (b)(6) 2018 (right hip).This pc is for the first revision of the right hip.See (b)(4) for the second revision.
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Manufacturer Narrative
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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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.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. 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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After review of medical records, it was also stated that the patient¿s pain level is severe and their functioning level is significantly decreased due to the wear of articular bearing surface of internal prosthetic hip joint.
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Manufacturer Narrative
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Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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In addition to what were previously alleged, litigation records alleges discomfort, dislocations, clicking noise and swelling.
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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 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 : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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Search Alerts/Recalls
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