OBERDORF SYNTHES PRODUKTIONS GMBH; PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
|
Back to Search Results |
|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body In Patient (2687); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
This report is for an unknown epoca/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient had an initial surgery on (b)(6) 2012, where a shoulder replacement model an unknown epoca was implanted during an unknown procedure.The patient had a test template (instrumental) implanted as the company had not sent the unknown epoca implants for the surgery.The patient will now undergo the revision surgery on an unknown date that will carried out in another hospital by another doctor.This report is for one (1) unknown epoca.This is report 1 of 1 for complaint (b)(4).
|
|
Search Alerts/Recalls
|
|
|