Primary surgery performed on 2016.It was reported that on (b)(6) 2018 patient felt an unusual sensation when standing up from a seated position, the joint felt loose and had a clicking noise.Patient knee and lower leg started to swell and pain increased.A scan was performed at (b)(6) hospital, where they diagnosed a burst bakers cyst.In (b)(6), patient contacted her surgeon; a joint x-ray was performed, doctor diagnosed a broken and displaced insert.A revision surgery was performed to correct the issue.During the operation it was discovered that the post on the insert had sheared off and the metal parts had worn on each other leaving significant metallic debris around the joint and metallosis.Since then, the second knee has taken much longer to recover and patient still needs the aid of crutches to walk significant distances and requires the nightly use of diclofenac 3% gel.
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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event was already reported on mdr, case no: 1020279-2019-00802, therefore, it was determined that this case does not meet the threshold for reporting.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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