ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROTHESIS HIP
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Model Number N/A |
Device Problems
Material Erosion (1214); Noise, Audible (3273); Migration (4003)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 12/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: 36mm i.D.Size g high wall liner item # 30123607 lot #64591563 modular neck p1 12/14 neck taper use with +0 heads only item #00784801301 lot #65438281 unknown cup item #unknown cup item and lot #unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that a patient underwent a left hip revision approximately two months post implantation due to instability, pain, squeaking, popping, and stiffness.Radiographic images indicated migration of head.During the revision, when the head was removed, metallosis and erosion were noted.The head, neck, and liner were exchanged without complications.The stem and cup remain implanted.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Event Description
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It was reported that a patient underwent a left hip revision approximately two months post implantation due to instability, pain, squeaking, popping, and stiffness.Radiographic images indicated migration of head.During the revision, when the head was removed, metallosis and erosion were noted and a liner disassociation from cup was noted.The head, neck, and liner were exchanged without complications.The stem and cup remain implanted.Due diligence is complete for this complaint; to date, the product has not been received and no additional information is required.
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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/corrected: updated: b5; g3; h2; h3; h6;d10.Corrected: d1;d2; d3, d4 ;h4.Upon reassessment of the reported event, it was determined that this event was reported on mdr360586 (0001822565 - 2024 - 00085 - 2).The initial report was forwarded in error and should be voided.
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