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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 05/03/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: cat#: 16-104156, lot#: 645350 rnglc+ ltd hole fin shl sz56.Cat#: 103533, lot#: 900690 ti low profile screw 6.5x30mm.Cat#: 51-104150, lot#: 6320163 tprlc 133 t1 pps ho 15x150mm.Cat#: xl-105894, lot#: 544650 arcomxl rlc 10deg 36mm sz24.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00958.
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Event Description
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It was reported that approximately 5 years post implantation of a right total hip arthroplasty, the patient was revised due to, fluid accumulation in the joint, and elevated metal ion levels.During surgery, metallosis was confirmed and determined to be related to the trunnion head interface.The head was removed, and the trunnion was noted to be a very short trunnion with a +9mm head high offset stem, which the surgeon believed predisposed the patient to metallosis.Metallosis was noted around the trunnion with black material on the inside of the head and the trunnion itself.All components were exchanged with competitor product without complications.No additional information was available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Additional information received that approximately 5 months prior to the patient¿s revision, 20ml was aspirated from the right greater trochanteric area due to pain.Numbing medication was injected without steroids.The pain was minimally resolved with injection; however, the pain returned.The patient remained on chronic prednisone therapy.A second injection was planned prior to the revision.No additional information available.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.H6: component code: mechanical (g04) - head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right total hip arthroscopy was performed.Approximately four years later, an aspiration occurred due to pain.The results showed inflammation.The patient was then revised due to pain, elevated metal ions, and metallosis.Black material was noted on the inside of the head and trunnion, and the trunnion was no longer smooth.All products were explanted and replaced with competitor products.This complaint was confirmed based on the provided medical records; however, 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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Search Alerts/Recalls
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