WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 33680003 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Fluid Discharge (2686); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 06/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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It was reported that the patient underwent a revision surgery due to pain, drainage and swelling.The patient had septic arthritis in the ankle due to an unspecified organism.The implants were removed and an antibiotic spacer was implanted.
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Manufacturer Narrative
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The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided, to confirm the reported infection.Microbiologist reviewed the sterility of the dhr and noted: the subject device was packaged according to established design and process specifications, and got sterilized acording to process.No deviation for a non-conformance could be found.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that the patient underwent a revision surgery due to pain, drainage and swelling.The patient had septic arthritis in the ankle due to an unspecified organism.The implants were removed and an antibiotic spacer was implanted.
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Search Alerts/Recalls
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