Model Number N/A |
Device Problem
Corroded (1131)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Reaction (2414)
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Event Date 05/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).It is unknown if product is being returned to zimmer biomet for investigation; however, an investigation has been initiated.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: 0001822565-2017-02180, 0001822565-2017-02181 and 0001822565-2017-02244.
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Event Description
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Legal counsel for patient reported patient was revised three years post-implantation due to discomfort, pain, and a tissue mass within the ileopsoas bursa suggestive of a metal-on-metal pseudotumor.Legal counsel further reported that during the procedure, there were signs of corrosion at the neck and stem junction, malfunction of the acetabular ring, and acetabular osteolysis.Attempts to obtain additional information have been made; however, no more is available at this time.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Device history report review was unable to be performed as the lot number of the device involved in the event is unknown.Reported event was unable to be confirmed as part number / lot number of device involved in the incident was unknown.Root cause was 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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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device is not a zimmer biomet product.The initial reports were submitted in error and should be voided.
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Event Description
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Upon receipt of additional information, it has been determined that this device is not a zimmer biomet product.The initial reports were submitted in error and should be voided.
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Search Alerts/Recalls
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