Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Adhesion(s) (1695); Metal Related Pathology (4530)
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Event Date 11/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog number:139266 lot number:961790 brand name: m2a magnum tpr insrt.Catalog number:157456 lot number: 814560 brand name: m2a magnum head.Catalog number:us157862 lot number:315260 brand name: m2a-magnum pf cup.Catalog number:192411 lot number:219480 brand name: echo por fmrl red nc.Multiple reports were submitted along with this report : 0001825034-2022-00598 and 0001825034-2022-00599.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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It was reported that the patient was revised due to elevated metal ions and adverse local tissue reaction approximately 9 years post implantation.During the revision there was no significant metal debris or staining, minimal tissue necrosis, and weakened posterior capsule.The head and taper adapter were exchanged without complication's.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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Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.
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Manufacturer Narrative
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Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.Initial report should be voided.
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Search Alerts/Recalls
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