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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035)
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Event Date 04/21/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00801803202 ¿ cocr head ¿ 61111778; 00630505032 ¿ xlpe liner ¿ 61106334; 00620005222 ¿ trilogy shell - 61126612; 00625006530 ¿ bone screw ¿ 61010553; 00625006520 ¿ bone screw ¿ 61026687.Customer has indicated that the product will not be returned to zimmer biomet for the investigation, as the product location is unknown.The investigation is in process.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: 0002648920-2020-00257, 0002648920-2020 00258.
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Event Description
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It was reported that patient underwent a left hip revision approximately 6 years post implantation due to pain, elevated metal ion levels, instability, and dislocation.During the revision, altr was apparent in the joint capsule along with corrosion on the taper with black discoloration and a ring of black corrosion debris.The head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting patient underwent a hip revision due to pain, instability, dislocation and elevated metal ion levels.Evidence of corrosion at the taper junction related to altr was noted in the capsule.There was cloudy, grayish, straw-colored fluid expressed from the joint.Dhr was reviewed and no discrepancies were found.The root cause is 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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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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