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Model Number N/A |
Device Problems
Mechanical Problem (1384); Unstable (1667); Noise, Audible (3273)
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Patient Problems
Pain (1994); Reaction (2414)
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Event Date 06/17/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products ¿ biomet m2a magnum cup, catalog#: us157852, lot#: 454850.Biomet bi-metric stem, catalog #: x180312, lot#: 767540.There are warnings in the package insert that these types of events can occur.Under possible adverse effects, number 1 states, "material sensitivity reactions.Implantation of foreign material in tissues may result in histological reactions involving various sizes of macrophages and fibroblasts." and, "particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid." number 10 states, "fretting and crevice corrosion may occur at interfaces between components." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records found no evidence of product nonconformance.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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Legal counsel for patient reported the patient underwent a right hip revision nine years post-implantation due to metal-on-metal complications.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Medical records indicate the patient was revised due to pain, instability and clicking from the joint, elevated metal ion levels and unspecified mechanical symptoms.Revision operative report notes metallosis, grey-staining and metallic-staining of the capsule, staining of the proximal femur trunnion, and proximal femur osteolysis.The femoral head and taper adapter were removed and replaced and a dual mobility bearing was implanted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified: a m2a-magnum mod hd sz 46mm, part # 157446 from lot 545290, was returned and evaluated against the complaint.Visual inspection found the head to scuffed and worn consistent with metal on metal construction.Tool marks were observed around the rim corresponding to the location of tool marks observed on the adapter.A m2a-magnum 42-50mm tpr insrt-3, part # 139254 from lot 708220, was returned and evaluated against the complaint.Visual inspection found scratching on the exposed face of the adapter.Tool marks were observed around the rim corresponding to the location of tool marks observed on the rim of the head.Visual examination of the conical taper of the m2a magnum taper adapter (lot 708220) shows damage in the form of dark debris and burnishing / scuffing.Reference photos.Additional information does not change the root cause of the previous investigation.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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