This complaint has been reported during a literature review performed by the post market surveillance group. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. 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. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10
The manufacturer became aware of a literature from (b)(6) college of medicine, united states. The title of this report is? Intermediate-term experience with the star total ankle in the united states? Which is associated with the stryker? Scandinavian total ankle replacement (star)? System. Within that publication, post-operative complications/ adverse events were reported, which occurred from january 1999 to 2013. It was not possible to ascertain specific device/patient details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 76 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses delayed wound healing followed by superficial irrigation and debridement. Resection of the anterior tibialis tendon and postoperative ankle foot orthosis wear, which led to wound healing. 2 out of 2 cases. The report states: "seventeen patients (12. 3%) required additional late procedures related to the taa other than for revision, fracture fixation, or fractured polyethylene exchange. [? ] four patients required reoperation for superficial irrigation and debridement due to delayed wound healing. Two of these patients required resection of the anterior tibialis tendon and postoperative ankle foot orthosis wear, which led to wound healing.?
Patient Sequence No: 1, Text Type: D, B5