WRIGHT MEDICAL TECHNOLOGY INC FLATCUT TALAR DOME SZ 4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 33680034 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Discomfort (2330); Numbness (2415); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 08/08/2023 |
Event Type
Injury
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Event Description
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Clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): subject: (b)(6).As reported: "left ankle pain, swelling, and numbness.Patient was seen for 3 month follow up of left ankle on (b)(6) 2023 with complaints of pain, swelling, and numbness since last visit on (b)(6) 2023.Most of the pain was reported outside aspect of ankle.Examination showed well-healed scar with tenderness of left subtalar joint with minimal discomfort lateral aspect of the ankle.Radiographic imaging showed no evidence of lucency.Around the hardware.Patient is to continue wearing boot, physical therapy, use voltaren gel, and stabilize the ankle with prescribed lace-up ankle brace.".
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text: device disposition unknown.
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Event Description
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Clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): subject (b)(6).As reported: "left ankle pain, swelling, and numbness patient was seen for 3 month follow up of left ankle on (b)(6) 2023 with complaints of pain, swelling, and numbness since last visit on (b)(6) 2023.Most of the pain was reported outside aspect of ankle.Examination showed well-healed scar with tenderness of left subtalar joint with minimal discomfort lateral aspect of the ankle.Radiographic imaging showed no evidence of lucency.Around the hardware.Patient is to continue wearing boot, physical therapy, use voltaren gel, and stabilize the ankle with prescribed lace-up ankle brace.".
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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.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.
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