UNKNOWN ZIMMER POST
Received Aug 10, 2017
Report 0001822565-2017-05600 · MDR key 6786211
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4), CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT - UNKNOWN STEM CATALOG # NI LOT # NI, UNKNOWN ADAPTER CATALOG # NI LOT # NI, UNKNOWN HEAD CATALOG # NI LOT # NI, UNKNOWN GLENOID CATALOG # NI LOT # NI. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 0001822565 - 2017 - 05556, 0001822565 - 2017 - 05597, 0001822565 - 2017 - 05599, 0001822565 - 2017 - 05596.
Description of Event or Problem
IT IS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Additional Manufacturer Narrative
UPON RECEIPT OF ADDITIONAL INFORMATION, THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THE MDR HAS NOT BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001825034-2017-06991.
Description of Event or Problem
IT IS REPORTED THAT THE SURGEON HAD DIFFICULTY INSERTING THE BEARING.