Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4), d10 - medical product: femur cemented catalog # 42504605812 lot # 65604351 tibia fixed stem extension catalog # 42542007102 lot # 65503331 articular surface fixed bearing constrained condylar knee (cck) catalog # 42522800612 lot # 64615548 stem extension offset splined uncemented catalog # 42560613512 lot # 65645041 stem extension offset splined uncemented catalog # 42560613514 lot # 65703571 tibial augment cemented half block catalog # 42555805405 lot # 65085595 mri sterile short osteotome blade 12mm catalog # 47996602122 lot # 56715440 h3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2023-01816 0001822565-2023-01817 0001822565-2023-01818 0001822565-2023-01819 0001822565-2023-01820 0001822565-2023-01821 h3 other text : remains implanted.
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Event Description
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It was reported patient is experiencing ambulation difficulties, pain, swelling, redness in knee post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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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.It was previously reported on mfr#: 0001822565-2023-01822-1 that this event was considered non-reportable on behalf of zimmer biomet.However, upon receipt of additional information, it has been determined that report#: 0001822565-2023-01822-1 was drafted and submitted erroneously.This event remains reportable as it has been indicated the patient has suffered a serious injury.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported patient is experiencing ambulation difficulties, pain, swelling, redness in knee post implantation.It was further reported that the patient's pain levels are out of control, and they cannot walk unassisted.There is a future arthroscopy planned.Attempts to obtain additional information have been made; however, no more is available.
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Event Description
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No additional information.
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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: b4, d4, g3, h2, h3, h4, h6 visual examination of the provided picture identified the patient as having swollen lower legs and ankles.No product was returned, or pictures of the products provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Compatibility of the devices was reviewed with no issues noted.Medical records were provided and reviewed by a healthcare professional.Review of the available records identified that the patient was experiencing pain, swelling, ambulation difficulties, and could not walk unassisted due to pain.A definitive root cause could not 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.This complaint has been confirmed by the presence of nickel.The additional information received does not change 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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Search Alerts/Recalls
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