Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)
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Event Date 02/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog number: us157852 lot number: 932370 brand name: m2a-magnum pf cup.Catalog number:139252 lot number:764820 brand name: m2a-magnum 42-50mm.Catalog number:11-103204 lot number:604530 brand name: taperloc por fmrl.Catalog number: 157446 lot number: 535600 brand name: m2a-magnum mod hd.Multiple reports were submitted along with this report.0001825034-2022-01849.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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T was reported that the patient was revised due to pain and elevated metal ions approximately 12 years post implantation.During the revision, metal-stained tissue was debrided, pseudotumor was removed, and multiple areas of scar tissue were debrided.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - head.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: complication of internal left hip prosthesis ¿ hip pain associated with recalled total hip arthroplasty hardware.Elevated metal ions levels; based on her symptoms and serum iron levels, elected for revision.Prior to reaching the fascia of the gluteus maximus, found pseudotumor- debrided.Metal stained tissue was debrided.Trochanteric bursa had significant inflammatory tissue with minimal metal stained tissue.Debrided scar tissue, substantial amount of scar tissue underneath the gluteus medius anteriorly- debrided.Procedure findings: metallosis.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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