Model Number N/A |
Device Problems
Metal Shedding Debris (1804); Improper Chemical Reaction (2952)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); No Code Available (3191)
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Event Date 01/26/2015 |
Event Type
Injury
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Event Description
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It was reported the patient underwent a total hip arthroplasty on (b)(6) 2003.Subsequently, the patient was revised on (b)(6) 2015 due to a reaction to metal debris.All components were removed and replaced.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "material sensitivity reactions." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-00448 / 00449).
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2015-00448 / 00449 & 2017-00083).
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Event Description
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Patient underwent a left hip revision procedure approximately 12 years post-implantation due to left hip pain, decreased range of motion, and reaction to metal debris.During the revision, well-fixed femoral and acetabular components, significant erosion of the greater trochanter, and corrosion at the head-taper junction were noted.All components were removed and replaced and a poly bearing was implanted.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant medical products: pn: 10-104052, ln: 382360, m2a-t m/h rad 2hl shl.Pn: 162311, ln: 646440, bi-metric porous fmrl.
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Search Alerts/Recalls
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