TORNIER S.A.S. AEQUALIS RESURFACING HEAD 48 MM X 18 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number DWD806 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Bacterial Infection (1735)
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Event Date 02/07/2022 |
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 had a post-operative complication.The patient had to undergo re-operation without component change: arthroscopic debridement, adhesiolysis biopsies for cultures and sub acromial decompression, showing 2 positive bacterial cultures (1 for c acnes and 1 for gram positive rods).Patient has been treated with antibiotics.The adverse event is still ongoing.No additional information is available.
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Event Description
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It was reported that the patient had a post-operative complication.The patient had to undergo re-operation without component change: arthroscopic debridement, adhesiolysis biopsies for cultures and sub acromial decompression, showing 2 positive bacterial cultures (1 for c acnes and 1 for gram positive rods).Patient has been treated with antibiotics.The adverse event is still ongoing.No additional information is available.
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Manufacturer Narrative
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The reported event could be confirmed, since the pathology report confirm the infection of the patient.This conclusion was verified by a medical expert upon review of the patient's case documentation.The opinion of the medical expert state as following: "the pathology report confirms the inflammatory response in the glenohumeral joint and fits well with the infection that was diagnosed on the basis of the positive cultures." 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.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population." 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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