This file is a review of the following journal article: perret, m., et al (2021) return to professional australian rules football after surgery for traumatic anterior shoulder instability.The american journal of sports medicine, vol.49, pages 3066-3075 (australia).The study emphasizes on the investigation of the return-to-sport (rts) outcomes and complications after 2 different procedures for traumatic anterior shoulder instability in professional afl players.The patients evaluated on course of this study: 54 players.The article describes the following procedure: latarjet procedure or capsulolabral stabilization.The devices involved were: unknown laterjet implants.Complications described: 1 washout of a hematoma.1 capsulolabral decompression and removal of loose body (tissue).1 loose screw (implant) removal.1 late propionibacterium acnes infection treated with debridement, metal work removal, and hydro-dilatation.1 hydro-dilatation for considerable postoperative stiffness.
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This report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary =the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).Attempts were done to obtain more information from the author, however, no response was received.It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.Device history lot = given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed, or sterile load review could not be conducted.If the lot number becomes available, the mre review will be performed.
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