Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Erosion (1750); Osteolysis (2377)
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Event Date 11/01/2022 |
Event Type
Injury
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Event Description
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It was reported patient underwent left hip revision approximately 1-year post implantation due to significant bone loss resulting in loosening of the cup.No additional information on the reported event.
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Concomitant medical products: 00625006520- bone screw self-tapping 6.5 mm dia.20 mm length- 64615051; 00625006520- bone screw self-tapping 6.5 mm dia.20 mm length- j6963834; 00625006540- bone screw self-tapping 6.5 mm dia.40 mm length- j6923630; 00625006525- bone scr 6.5x25 self-tap- j6925770; 110010267- g7 osseoti multihole 58mm g- 7121443; 31-323240- 3.2mmx40mm rnglc+ acet drl bit- 614350; ep-200152- act artic e1 hip brg 28x46mm- 735920; 110024465- g7 dual mobility liner 46mm g- 492650.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2022 - 00235; 0002648920 - 2022 - 00236; 0002648920 - 2022 - 00237; 0002648920 - 2022 - 00238.Customer has indicated that the product will not be returned to zimmer biomet for investigation, requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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: g3; h2; h3; h6 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.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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No additional information on the reported event.
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Search Alerts/Recalls
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