Device Problems
Loss of or Failure to Bond (1068); Failure to Osseointegrate (1863); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); No Information (3190); Insufficient Information (4580)
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Event Date 07/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.Concomitant medical products: item# unk/ unk head / lot # unk, item# unk/ unk cup / lot # unk, item# unk/ unk liner/ lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2019 -05480, 0001822565 -2019 -05485, 0001822565 -2019 -05486.
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Event Description
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It has been reported that patient has sustained 2 separate injuries due to unknown reasons, however no revision has been reported to date.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 unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D6: (b)(6) 2018.D7: (b)(6) 2019.The additional information does not change the outcome of the previous investigation.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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It was reported patient underwent revision surgery approximately a year and four months post implantation due to loosening of the stem component.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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No further event information available at the time of this report.
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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: e1; e2; e3; g3; h2; h6.
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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: medical records were received and review noted patient was revised due to loosening and migration of the cup and subsequently, a second revision due to pain and difficulty ambulating.Within the joint, the stem was found to be loose with a lack of ingrowth noted.The stem and head were revised.The additional information does not change the outcome of the previous investigation.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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Event Description
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
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Manufacturer Narrative
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
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Search Alerts/Recalls
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