CARTIVA, INC UNKNOWN CARTIVA IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
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Catalog Number UNK_WCA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 09/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
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Event Description
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It was reported through the filing of a lawsuit that allegedly the patient was implanted with a cartiva right toe implant.It is further alleged the patient "developed profound dysfunction, swelling, and severe pain".Approximately 19 months post-op, the patient followed up with the surgeon, who "noted tenderness with palpation underneath the sesamoid.The patient had decreased range of motion in the first metatarsal - getting approximately 5 degrees of dorsiflexion and plantarflexion".The surgeon recommended revision surgery and the patient was revised 22 months post-op.
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Event Description
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It was reported through the filing of a lawsuit that allegedly the patient was implanted with a cartiva right toe implant.It is further alleged the patient "developed profound dysfunction, swelling, and severe pain".Approximately 19 months post-op, the patient followed up with the surgeon, who "noted tenderness with palpation underneath the sesamoid.The patient had decreased range of motion in the first metatarsal - getting approximately 5 degrees of dorsiflexion and plantarflexion".The surgeon recommended revision surgery and the patient was revised 22 months post-op.
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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