GENDER SOLUTIONS PFJ TROCHLEA COMPONENT
Received Apr 28, 2015 · Event occurred Nov 5, 2014
Report 1822565-2015-00623 · MDR key 4736170
Device
Product problems
- Off-Label Use
Patient
56 YR
- No Information
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.
Additional Manufacturer Narrative
EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A COMPLAINT HISTORY SEARCH INDICATED THERE ARE NO OTHER COMPLAINTS RELATED TO SPECIFIED PART AND LOT COMBINATION FOR THIS ISSUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF X-RAYS, PRODUCT OR FURTHER INFO. EVAL CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES AND CONFIRMED THAT THE DEVICE WAS LABELLED CORRECTLY AS "RIGHT". IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION OT THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem
IT IS REPORTED THAT A RIGHT IMPLANT AND WAS IMPLANTED INTO THE PT'S ;EFT KNEE.