ZIMMER BIOMET, INC. NONPOROUS TIBIAL BASEPLATE SIZE 3 LEFT FOR CEMENTED USE ONLY; PROSTHESIS KNEE
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Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Necrosis (1971)
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Event Date 12/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Implant date: february 2013.Date of event, explant date: (b)(6) 2013.Medical product: gender solutions male (gsm) femoral component catalog # 00541201601 lot # unknown.Rotating platform articular surface ultracongruent size 0 left 13 mm height catalog # 00543201013 lot # unknown.All poly patella size 1 8 mm thickness catalog # 00542000801 lot # unknown.Report source: (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 filled for this event: 0001822565 -2022 -01373.
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Event Description
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It was reported patient underwent a revision procedure ten months post implantation due to necrosis and subsidence.Attempts to obtain additional information have been made; however, no more is available 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 filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b3, b4, b5, d4, d6a, d6b, d10, e1, g3, g6, h1, h2, h4.D10: gender solutions male (gsm) femoral component catalog # 00541201601 lot # 62128265.Rotating platform articular surface ultracongruent catalog # 00543201013 lot # 61114274 all poly patella catalog # 00542000801 lot # 61796942.
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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, g3, g6, h1, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 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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Search Alerts/Recalls
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