Model Number N/A |
Device Problems
Corroded (1131); Material Discolored (1170); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Local Reaction (2035)
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Event Date 09/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign: country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565 - 2022 - 00865.
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Event Description
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It was reported the patient underwent a hip revision approximately 7 years post implantation due to pain and a confirmed pseudo-tumor.There was some black discoloration on the inside of the head and on the trunnion of the neck.No additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D6a: implanted (b)(6) 2014.H6: component code mechanical (g04): head.Visual examination of the returned product identified the conical taper of both devices to exhibit dark debris.The eliliptical taper of the neck shows damage in the form of burnishing and gouges.Damage is also seen between the conical and elliptical tapers.Additionally, the head and neck were sent to sem analysis.The tapers of the returned devices were reviewed via optical microscopy.Both tapers were assigned the consensus modified goldberg score of 4 corresponding to the surface with a severe corrosion attack and abundant corrosion debris.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 event information to report at this time.
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Search Alerts/Recalls
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