Correction b2, h6 clinical the reported event could be confirmed, since the device was returned indicating a revision surgery was performed.The device inspection revealed the following: the device was returned in a container with a small amount of saline.Device exhibits translucent, whitish hue throughout the body.Visual examination of the implant found the articulating surface to be partially smooth and partially scratched and indented.These indentations also had some material ¿tags¿ around the edges, indicating they could have been caused by more recent damage, such as implant removal.Medical affairs was consulted on the details of this case.Per their review, "this case is about a patient with a longstanding, progressive osteoarthritis of the first mtp-joints (the rigidity coming with that explains the term hallux rigidus) and an interphalangeal hallux valgus on both sides.The latter being corrected with a closing wedge osteotomy of the distal phalanx in both feet, that was stabilized with a small staple.The hallux rigidus was surgically treated with a cartiva implant in the mtp i joints of both feet.The x-ray shows an end-stage osteoarthritis with deformation of the mtp i joint surfaces and a subchondral cyst on the right mtp i joint.Due to the progression of the disease the cartiva implant is not functional any longer.Without further clinical information, this may explain the choice for a fusion of the joint." although the device was returned, the root cause was unable to be determined with the available information.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.A review of the device history was not possible because the lot number was not communicated.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 any additional information is provided, the investigation will be reassessed.
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