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Model Number N/A |
Device Problem
Difficult or Delayed Separation (4044)
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Patient Problem
No Information (3190)
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Event Date 07/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 139252, m2a-magnum 42-50mm tpr insrt-6, lot: unk, part: 157444, m2a-magnum mod hd sz 44mm, lot: unk.Multiple mdr reports were filed for this event, please see associated reports: taper: 0001825034-2019-03125, head: 0001825034-2019-03126.
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Event Description
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It was reported that during revision surgery, the metal head would not disengage/release from the trunnion during explanation.It was completely incarcerated on the trunnion.You could see black corrosive material around it.Multiple methods were used, head finally released from the trunnion.The process took a full hour to get the head and adapter off.Extensive corrosion was noted.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The event was confirmed with medical records received.Initial op notes demonstrated that the patient had right tha due to severe degenerative arthritis.Revision op notes observed the patient was revised due to pain, noise, and elevated metal ions.During the revision procedure, it was noted that a pseudotumor with extensive tissue damage and osteolysis was present in conjunction with implant wear and corrosion.The patient experienced pain, clunking, popping sensations.A large pseudotumor was excised around the acetabular component.There was bone loss around acetabulum and femoral component.Cell count came back negative.The head won¿t come off and there was black corrosive material around it.After the taper adapter was removed, there was extensive black corrosive wear inside the adapter and on the trunnion.It took an hour to remove the head and taper adapter.A definitive root cause cannot be determined.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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Device malfunction leading to increased surgical time and patient risk.
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Search Alerts/Recalls
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