Catalog Number UNK_ENO |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problems
Erythema (1840); Synovitis (2094)
|
Event Date 05/01/2020 |
Event Type
Injury
|
Event Description
|
It was reported within a publication by aristotelis kaisidis that the patient presented "synovitis, superficial wound erythema, and deterioration in range of motion.Removal of the inspace device arthroscopically, without any other internal signs of infection.".
|
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.The catalog number is not known at this time, therefore the gtin could not be determined.However, should it become available it will be provided in future reports.
|
|
Manufacturer Narrative
|
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient synovitis.Probable root cause: design: - inadequate raw material specification.Process: - spacer not manufactured to specification.- incorrect material used during manufacture.- incorrect packaging or error in packaging process causes exposure to humidity or high temperatures.Application: - use of expired product.- wrong storage conditions (high temperatures or exposure to humidity <40%).- re-use of single-use device.- use of contrast media.- wrong patient or device selection.- patient not following rehab procedure.Manufacture date is not known.H3 other text : 81.
|
|
Event Description
|
It was reported within a publication by aristotelis kaisidis that the patient presented "synovitis, superficial wound erythema, and deterioration in range of motion.Removal of the inspace device arthroscopically, without any other internal signs of infection.".
|
|
Search Alerts/Recalls
|