Model Number N/A |
Device Problems
Loss of or Failure to Bond (1068); Insufficient Information (3190)
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Patient Problems
Erosion (1750); Pain (1994); Swelling (2091); Osteolysis (2377); No Information (3190)
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Event Date 01/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05099, 0001822565 - 2019 - 05101, 0001822565 - 2019 - 05102.
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Event Description
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It was reported patient underwent an unknown revision after an unknown amount of time post implantation due to unknown reasons.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.Concomitant medical products: item#:00111214001;palacos r 1x40 single lot#:7714364.Item#:00598005701;stemmed tibial component precoat size 7 lot#:62369770.Item#:00599601751;femoral component option for cemented use only size g left lot#:62438666.Item#:00598009000;stem extension replacement screw lot#:62454245.Item#:00596009900;taper stem plug lot#:62448307.Item#:00596405010;articular surface size gh 10 mm height "use with plate 7 lot#: 62463371.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-05099 and 0002648920-2020-00133.
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Event Description
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The patient was revised approximately four years, three months after his initial left tka due to pain and swelling.Radiology reviews revealed osteolysis and erosions under the medial tibial plateau which the surgeon attributed to early loosening of the tibial stem.During the revision, a fracture was noted on the medial tibial plateau and erosions confirmed.The tibial components were revised without complication, the patella was resurfaced, and the femoral components were left intact.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were reviewed and identified the patient reported feeling a sudden change in their knee with pain and swelling.Office x-rays revealed osteolysis and erosions under the tibial plateau medially.During the revision fracture was noticed across the medial tibial plateau and erosion was noted medially.The femur was noted to be intact.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 reported.
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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: b4; b5; d4 (lot); g4; g7; h1; h2.
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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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Search Alerts/Recalls
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